System and method for treating soft tissue with force impulse and electrical stimulation

ABSTRACT

A system for treating soft tissue of a patient. The system includes a treatment head and a computer portion. The treatment head includes a probe and an electrode operably coupled to the probe. The probe and electrode are configured to respectively deliver a mechanical force impulse and an electrical stimulation to the soft tissue when placed in operable contact with the soft tissue. The computer portion includes a CPU and is configured to coordinate the delivery of the mechanical force impulse and electrical stimulation relative to each other. The system is configured to sense a shockwave in the soft tissue of the patient, the shockwave resulting from the mechanical force impulse delivered to the soft tissue via the probe. The system is also configured to analyze a characteristic of the sensed shockwave and configure the electrical stimulation to be delivered to the soft tissue via the electrode based on the characteristic analysis of the sensed shockwave. The characteristic may be at least one of frequency of the sensed shockwave, amplitude of the sensed shockwave, and/or wave shape (form) of the sensed shockwave.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation application of U.S. application Ser.No. 14/372,989 filed Jul. 17, 2014, which application is a nationalstage entry of Patent Cooperation Treaty patent application No.PCT/US2013/021973 filed Jan. 17, 2013, which claims priority to: U.S.Provisional Patent Application No. 61/587,484 filed 17 Jan. 2012. Thecontents of the above-mentioned patent applications are herebyincorporated by reference in their entireties.

FIELD OF THE INVENTION

Aspects of the present invention relate to medical systems and methods.More specifically, the present invention relates to medical systems for,and methods of, treating soft tissue of a patient in a medicalenvironment such as, for example, physical therapy.

BACKGROUND OF THE INVENTION

Measurement and treatment of soft tissue has been an issue in manualmedicine since its inception. Doctors and therapist have always reliedon their skills to be able to assess and treat soft tissue problems. Theproblem is that that there is no way to accurately deliver or recordthese forces and scientifically measure the results via a dynamicresponse either before, during or after treatment.

There is a need in the art for a system for, and method of, measuringand treating soft tissue.

BRIEF SUMMARY OF THE INVENTION

Disclosed herein is a system for treating soft tissue. In oneembodiment, the system includes a piezoelectric sensor and an electrode.The piezoelectric sensor is positioned between a probe and an anvildriven by an armature driven by a coil of a solenoid. Displacement ofthe anvil causes displacement of the probe, and the piezoelectric sensorgenerates a waveform from a force impulse traveling through the probe onaccount of the probe being displaced against the soft tissue. Theelectrode is supported on the probe and configured to both administerelectrical stimulation to the soft tissue and sense a galvanic responseof the soft tissue.

Also disclosed herein is a method for treating soft tissue. In oneembodiment, the method includes: select a region of soft tissue fortreatment; select a preload tissue compression force and apply thepreload tissue compression force to the region, reading and analyzing atissue signal resulting from the applied preload tissue compressionforce; read a pretreatment galvanic response of the region; select atype of electrical stimulation with respect to power and type ofwaveform; select a mode of application of electrical stimulation withrespect to continuous current or pulsed current; select a mode ofapplication of percussive impact treatment; apply simultaneouslyselected percussive impact treatment and selected electrical stimulationtreatment type and mode to region via probe and electrodes,respectively; measure soft tissue characteristics of region viapiezoelectric sensors; use electrodes to monitor application of, andresponse to, electrical stimulation during treatment; read galvanicresponse of region post treatment, store and compare to pretreatmentgalvanic response; display stored galvanic responses and a differencebetween the two; and determine change in soft tissue characteristicsfrom change in galvanic response and/or difference in soft tissuecharacteristic determined via piezoelectric sensor.

Also disclosed herein is a system and process for the application of lowlevel electrical stimulation to soft tissue, dermatomes, nerves andmuscles. In one embodiment, the system includes an impulse and sensinghead capable of determining the elasticity of soft tissue by applying aforce impulse to soft tissue including ligaments, fascia and musclewhile at the same time imparting an electrical impulse to stimulatemuscles and nerves. The application of the system can be eitherdetermined by the therapist or guided by protocols associated withtypical manual protocols used in physical medicine specific to but notlimited to physical therapy protocols for the purpose of post-operative,rehabilitative and pain abatement outcomes.

Also disclosed herein is a system for the therapeutic treatment ofmusculoskeletal disorders. The system is configured to simultaneouslyapply to living tissue electrical stimulation and percussive force. Thesystem includes hardware and software that allows a medical treatmentprovider to set and control the treatment via a software interface, thesoftware being configured to control a preload force (e.g., tissuecompression), the application of a percussive force, and electricalstimulation. The software may allow the medical treatment provider toselect: the percussive force settings; the type of electricalstimulation based on power and waveform type; and the mode ofapplication of the electrical stimulation, such as, for example,continuous or pulsed. Further, the software may allow a medicaltreatment provider to select a treatment area on anatomical drawingsdisplayed on a computer display, the selection being recorded for use inthe treatment of the soft tissue via a percussive impact and electricalstimulation under pressure. Also, the computer display may displayanatomical views of the human body such that tissues and/or bone areexposed to aid the medical treatment provider in the application ofpercussive force and electrical stimulation under pressure atappropriate points of treatment. Still further, the software may beconfigured to allow the selection of a predefined treatment protocol foruse in the treatment of soft tissue via a percussive impact andelectrical stimulation under pressure.

Also disclosed herein is a system for treating soft tissue of a patient.In one embodiment, the system includes a treatment head and a computerportion. The treatment head includes a probe and an electrode operablycoupled to the probe. The probe and electrode are configured torespectively deliver a mechanical force impulse and an electricalstimulation to the soft tissue when placed in operable contact with thesoft tissue. The computer portion includes a CPU and is configured tocoordinate the delivery of the mechanical force impulse and electricalstimulation relative to each other.

The computer portion may further include a memory, wherein the computerportion causes the electrical stimulation to be delivered relative tothe mechanical force impulse according to a treatment protocol stored inthe memory. For example, the treatment protocol may cause the electricalstimulation to be delivered generally simultaneously with the deliveryof the mechanical force impulse. Alternatively, the treatment protocolmay cause the electrical stimulation to be delivered subsequent to thedelivery of the mechanical force impulse.

The electrode may be further configured to sense a galvanic responseassociated with the soft tissue. Accordingly, the computer portion maydetermine a difference in galvanic response associated with the softtissue and use the difference in galvanic response to determine acharacteristic associated with the soft tissue. The computer portion canthen use the characteristic to determine an appropriate electricalstimulation to be delivered to the soft tissue via the electrode. Forexample, the appropriate electrical stimulation may include at least oneof hi voltage mono-phasic, hi voltage bi-phasic, Russian symmetricalbi-phasic, square wave mono-phasic, or square wave bi-phasic.

The treatment head further may further include a force impulse wavesensor configured to sense a frequency of the mechanical force impulseassociated with the soft tissue. Accordingly, the computer portion mayuse the sensed frequency of the mechanical force impulse associated withthe soft tissue response to determine a characteristic associated withthe soft tissue. The computer portion may then use the characteristic todetermine an appropriate electrical stimulation to be delivered to thesoft tissue via the electrode. For example, the appropriate electricalstimulation may include at least one of hi voltage mono-phasic, hivoltage bi-phasic, Russian symmetrical bi-phasic, square wavemono-phasic, or square wave bi-phasic.

The computer portion may further include a computer display thatdisplays a representative patient image. Selection of a specific regionof the representative patient image may cause the computer portion todetermine an appropriate electrical stimulation to be delivered to thesoft tissue via the electrode. For example, the appropriate electricalstimulation may include at least one of hi voltage mono-phasic, hivoltage bi-phasic, Russian symmetrical bi-phasic, square wavemono-phasic, or square wave bi-phasic.

The probe may include two tips and the electrode may include anelectrode on each tip. Alternatively, the probe may include a single tipand the electrode may include an electrode on the tip and an electrodeequipped patch separate from the tip.

Also disclosed herein is a method of treating soft tissue of a patient.In one embodiment, the method includes: a) cause a probe of a treatmenthead to contact the patient at a target treatment location; b) use theprobe to apply a preload tissue compression force to the targettreatment location; c) analyze a tissue signal resulting from theapplication of b); d) select an electrical stimulation to be deliveredto the target treatment location, the selection being based off of theanalysis of c); e) use the probe to deliver percussive impacts to thetarget treatment location; and f) use an electrode to deliver theelectrical stimulation selected in d) to the target treatment location.The electrode may be supported on the probe. The percussive impacts andelectrical stimulation delivered to the target treatment location may bedelivered generally simultaneously. The tissue signal of the analysis ofc) may include a galvanic response. Additionally or alternatively, thetissue signal of the analysis of c) may include a frequency associatedwith the target treatment location and resulting from the preload tissuecompression force. Also disclosed herein is a system for treating softtissue of a patient. In one embodiment, the system includes a treatmenthead and a computer portion. The treatment head includes a probe and anelectrode operably coupled to the probe. The probe and electrode areconfigured to respectively deliver a mechanical force impulse and anelectrical stimulation to the soft tissue when placed in operablecontact with the soft tissue. The computer portion includes a CPU and isconfigured to coordinate the delivery of the mechanical force impulseand electrical stimulation relative to each other. The system isconfigured to sense a shockwave in the soft tissue of the patient, theshockwave resulting from the mechanical force impulse delivered to thesoft tissue via the probe. The system is also configured to analyze acharacteristic of the sensed shockwave and configure the electricalstimulation to be delivered to the soft tissue via the electrode basedon the characteristic analysis of the sensed shockwave. Thecharacteristic may be at least one of frequency of the sensed shockwave,amplitude of the sensed shockwave, and/or wave shape (form) of thesensed shockwave.

The computer portion may further include a memory, wherein the computerportion causes the electrical stimulation to be delivered relative to atreatment mechanical force impulse according to a treatment protocolstored in the memory. For example, the treatment protocol may cause theelectrical stimulation to be delivered generally simultaneously with thedelivery of the treatment mechanical force impulse. Alternatively, thetreatment protocol may cause the electrical stimulation to be deliveredsubsequent to the delivery of the treatment mechanical force impulse.

The computer portion may include a memory, wherein the computer portioncauses the electrical stimulation to be delivered relative to atreatment mechanical force impulse according to a treatment protocolstored in the memory. The treatment protocol may be used to justifycontinuing to maintain an electrical stimulation treatment already beingadministered along with a percussive treatment. The treatment protocolmay also be used to justify changing the electrical stimulation protocolalready being administered along with a percussive treatment to anotherelectrical stimulation protocol.

Also disclosed herein is a system for treating soft tissue of a patient.In one embodiment, the system includes a treatment head and a computerportion. The treatment head includes a probe and an electrode operablycoupled to the probe. The probe and electrode are configured torespectively deliver a mechanical force impulse and an electricalstimulation to the soft tissue when placed in operable contact with thesoft tissue. The computer portion includes a CPU and is configured tocoordinate the delivery of the mechanical force impulse and electricalstimulation relative to each other. The CPU includes a memory includingan electrical stimulation protocol database containing multipletreatment protocols referenced to respective multiple afflictiondiagnoses. The multiple affliction diagnoses may include at least one ofmuscular dystrophy, multiple sclerosis, muscle atrophy due to stroke orparalysis, pre-operative surgical preparation, post-operative surgicalrecovery or physical therapy, or discopathy.

A first treatment protocol of the multiple treatment protocolsreferenced to a first affliction diagnosis of the multiple afflictiondiagnoses may have unique electrical characteristics as compared to asecond treatment protocol of the multiple treatment protocols referencedto a second affliction diagnosis of the multiple affliction diagnoses.The unique electrical characteristics may include at least one ofwaveform type, output voltage, output current, output frequency, outputtime, or number of pulses.

The first treatment protocol of the multiple treatment protocolsreferenced to a first affliction diagnosis of the multiple afflictiondiagnoses may have unique operator instructions as compared to a secondtreatment protocol of the multiple treatment protocols referenced to asecond affliction diagnosis of the multiple affliction diagnoses. Theunique operator instructions may include at least one of electrodenumber, electrode placement location on the patient body, or probeplacement location on the patient body.

While multiple embodiments are disclosed, still other embodiments of thepresent disclosure will become apparent to those skilled in the art fromthe following detailed description, which shows and describesillustrative embodiments of the disclosure. As will be realized, theinvention is capable of modifications in various aspects, all withoutdeparting from the spirit and scope of the present disclosure.Accordingly, the drawings and detailed description are to be regarded asillustrative in nature and not restrictive.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a cross-sectional side view of an impulse and sensing head ofthe system.

FIG. 2 is a schematic diagram showing the hardware components of thesystem used to create and capture the wave form.

FIG. 3 depicts the thoracic analysis computer screen in the preferredembodiment.

FIG. 4 depicts the lateral cervical analysis computer screen in thepreferred embodiment.

FIG. 5 shows a computer screen displaying a summary of the peakamplitudes taken from the wave forms on FIG. 3.

FIG. 6 shows a computer screen displaying a summary of the peakamplitudes taken from the wave forms in FIG. 4.

FIG. 7 shows a computer screen depicting a wave form which has derivedinformation from each of the screens shown in FIGS. 3 and 4.

FIG. 8 shows a computer screen displaying a treatment screen.

FIGS. 9 through 12 are a sample of charts that may be produced so thatdata may be presented in an informational format for comparison.

FIG. 13 is a diagrammatic depiction of an embodiment of the system.

FIG. 14 is a flow chart illustrative of the operation of an embodimentof the system.

FIG. 15 is a flow chart illustrating a methodology for selecting anelectrical stimulation protocol based off of a measured tissue frequencyof percussive impulses.

FIG. 16 is a diagrammatic depiction of a database or library that existsin the memory for use with the methodology discussed with respect toFIG. 15.

FIG. 17 is a flow chart illustrating a methodology of for selecting anelectrical stimulation protocol based off of a measured galvanicresponse.

FIG. 18 is a diagrammatic depiction of another database or library thatexists in the memory for use with the methodology discussed above withrespect to FIG. 17.

FIG. 19 is a method flow chart for a treatment display screen that maybe displayed on the touch screen of the computer interface.

FIG. 20 illustrates an EStim setup display arrangement on the touchscreen that may form part of the computer interface.

FIG. 21 is the same view as FIG. 20, except showing a pull down menuactivated via the mode button.

FIG. 22 is the same view as FIG. 20, except showing a pull down menuactivated via the waveform button.

FIG. 23 is a method flow chart illustrating the continuation of themethod illustrated in FIG. 19.

FIG. 24 is a method flow chart illustrating the continuation of themethod illustrated in FIG. 23.

FIGS. 25A-25J shown side elevation views of various probe embodiments.

FIG. 26 is a flow chart illustrating another operational methodology forthe system and its touch screen interface.

FIG. 27 is a flow chart for a treatment screen when the treatment headis pressed against the patient and the preload threshold is met.

FIG. 28 is a flow chart illustrating a shockwave subsystem data event.

FIG. 29 is a flow chart illustrating an embodiment of the methodology ofsetting up the Estim subsystem based on a shockwave data analysis.

FIGS. 30-32 illustrate the EStim setup wherein an affliction diagnosisis used to select an EStim treatment protocol from an EStim treatmentprotocol database.

FIG. 33 illustrates an EStim treatment protocol database whereinspecific affliction diagnoses are referenced to specific EStimprotocols.

FIG. 34 is a block diagram of a preoperative and postoperative treatment(“PAPT”) application configured to operate on a computing device.

FIG. 35 is a block diagram of a stored treatment protocol selectionmodule of PAPT application.

FIG. 36 is a flow chart illustrating an embodiment of a stored treatmentprotocol selection module.

FIG. 37 is a block diagram of a tissue assessment module of a tissuetreatment application.

FIG. 38 is a block diagram of a trigger point analysis module.

FIG. 39 is a flow chart illustrating an embodiment of a trigger pointanalysis module.

FIG. 40 is a block diagram of a preoperative and postoperative treatment(“PAPT”) module.

FIG. 41 is an embodiment of a tissue treatment guidance displaydepicting a patient hip that is to be the target of a surgicalprocedure.

FIG. 42 is an embodiment of a tissue treatment guidance displaydepicting a patient knee that is to be the target of a surgicalprocedure.

FIG. 43 is an embodiment of a tissue treatment guidance displaydepicting a patient foot that is to be the target of a surgicalprocedure.

FIG. 43A is an embodiment of a tissue treatment guidance displaydepicting a patient shoulder that is to be the target of a surgicalprocedure.

FIG. 44 is a flow chart illustrating an embodiment of a tissue treatmentmodule.

FIG. 45 is an isometric view of an embodiment of the physical therapytreatment system for treating the tissue of a patient, wherein a case orhousing that encloses and protects the system is closed.

FIG. 46 is an isometric view of the physical therapy system of FIG. 45,wherein the case or housing is opened up to reveal the display, inputdevice, impulse stimulator instrument and electrodes.

FIG. 47 depicts another GUI for display on the display depicted in FIG.46, wherein the GUI is associated with the setup of the system for thetreatment of a patient hip.

DETAILED DESCRIPTION

Disclosed herein is a system 1111 for, and method of, measuring andtreating soft tissue of a patient. The system 1111 is configured forboth (1) electrical stimulation of human or animal soft tissue viaelectrodes 14, and (2) imparting force via a percussive shockwave intohuman or animal soft tissue including, for example, ligaments, fascia,and muscle. The system 1111 is also configured to record via a computerprogram 38 the results of the imparted force and/or the electricalstimulation.

In one embodiment, the system 1111 is configured for the measurement ofsoft tissue response arising from the application of a force impulseand/or electrical stimulus to the soft tissue. In one embodiment, thesystem includes an impulse and sensing head 44 capable of determiningtissue response. The impulse and sensing head 44 is configured to applya percussive force impulse to soft tissue including, for example,ligaments, fascia or muscle or a combination thereof, and generating awave form characteristic of the energy absorption profile. Additionally,the system 1111 also includes conductive probes 13 for the purpose ofproviding electrical stimulation, which is computer controlled, to theskin and dermatomes.

The system 1111, for example, at its impulse and sensing head 44,includes signal generating components attached to the data acquisitioncircuitry 45 of the head 44 so a signal will be captured by the dataacquisition circuitry of the computer portion 45 of the system 1111.Data acquisition circuitry of the computer portion 45 also captures thewave form and a signal characteristic of the resultant force impulsethat is indicative of the energy absorption of said tissue.

In one embodiment, the impulse and sensing head 44 includes a probe 13,a piezoelectric sensor 11 firmly attached to the probe 13, an anvil 9firmly attached to the sensor 11, an electromagnetic coil 5 and anarmature 7. The armature 7 is inserted without attachment into theelectromagnetic coil 5 and configured so that when the coil 5 isenergized, the armature 7 is accelerated to impact the anvil 9 andthereby produce the force impulse, which travels through thepiezoelectric sensor 11 and causes the piezoelectric sensor 11 togenerate the wave form. A pressure sensor 3 is attached to the head 44and configured so that when the probe 13 is pressed against the tissueand reaches a predetermined pressure, the pressure sensor 3 causes arelease of a burst of current that energizes the electromagnetic coil 5.The pressure sensor 3 is also attached to the signal generatingcomponents, which output data, characteristic of the pressure of theprobe 13 in contact with the tissue, to the computer 45.

In one embodiment, the tip of the system is constructed with electrodes14 that are designed to make contact with the skin. At the same instantthe force impulse is delivered via the armature 7 being accelerated toimpact the anvil 9, an electric pulse is generated and delivered viaelectrodes 14 to the patient in either a continuous current or as apulse as selected within the software 38.

In one embodiment, the data acquisition circuitry 45 includes a computer34, which has a screen 36. An illustration of the soft tissue isdisplayed on the screen 36. Information indicating the force impulse,the pressure of the probe 13 and the wave form are stored in thecomputer 34. This information can be merged together, sorted, and loggedfor each patient. The computer 34 can recall and print this information.The software 38 also allows for various configurations of the electricalstimulation impulse that allows for various types of waveforms andfrequencies and power settings.

The graphic display on the computer screen 36 is configured to showparts of the body and allows the doctor or therapist to choose the areaof the measurement by using a touch screen 500 to identify and log thearea of measurement. Additionally there are pre-programmed protocolsthat can be used to guide the doctor in the application of the system1111 for specific conditions.

The system 1111 uses a computer algorithm that may use baseline muscletension data and/or baseline ligament tension data to give the doctor ortherapist information regarding the characteristics of the soft tissue.

The system 1111 can also be used to treat patients. The probe 13 of theinvention may oscillate by repetitively accelerating the armature 7 toimpact the anvil 9 at a controlled frequency and a predetermined timeperiod. Also, electrodes 14 on the tips 12 of the probes 13 can be usedto administer electrical stimulation at the tips 12 of the probes 13.Accordingly, the system 1111 can be applied to the soft tissue to resetthe firing patterns of muscle spindle fibers via force impulses while atthe same time exciting muscle spindle fibers and dermatomes withelectrical stimulation. Preferably, the frequency may be varied betweenapproximately 0.1 Hertz and approximately 12 Hertz in increments ofapproximately 0.1 Hertz. The electrical stimulation falls within therange used for this common therapy. For example, the electricalstimulation may be varied between approximately 0.1 and approximately150 Hz.

With respect to soft tissue treatment measurement via piezoelectricsensing devices 11 and the logging of the amplitude of the wave formoutput from such piezoelectric sensing devices 11, there is complexityin the differing shapes of the wave forms elicited during the mobilitytesting of soft tissue. Initial experiments and demonstrations haveshown that there is useful information trapped in each wave form outputof a piezoelectric sensor 11 interposed in a percussion system fortesting soft tissue response. The system 1111 employs a method ofcapturing the mathematic representations of the wave form output fromthe percussive testing of soft tissue and then manipulating andinterpreting such mathematic representations so as to define the amountof soft tissue resistance or mobility and the condition andcharacteristics of such tissue resistance or mobility.

The system 1111 is configured to analyze the relationship of all of theresponse factors associated with soft tissue treatment and measurement,namely the analysis of the waveforms as they relate to soft tissue ingeneral. The relation to the stiffness characteristic (waveform peak),the hysteresis function (wave shape), and the frequency response providevaluable information regarding the state of the measured tissue.

In one embodiment, the electrical stimulation unit 100 of the system1111 employs a high frequency oscillator 105 and a power amplifier 110to generate a high frequency electrical signal that is then delivered toa transducer, such as an electrode 14. The electrical energy is thentransmitted to the patient by applying a probe contact supportedelectrode against the patient's skin. The amplitude of the electricalsignal plays a role in the electrical stimulation of the system 1111because the lower the amplitude of the electrical signal, the moretolerant the patient is to the stimulation transmitted by the electrode14.

All tissues in the human body, including skin, have the ability toconduct electricity. Indeed, this is how nerves function to relayinformation from one part of the body to another. The skin also haselectrical activity, which is in constant, slight variation, and can bemeasured and charted. The skin's electrical conductivity fluctuatesbased on certain bodily conditions, and this fluctuation is called thegalvanic skin response.

Sudden changes in emotion, such as fright, can trigger the galvanic skinresponse, as can other types of changes, such as the hot flashes thatare characteristic of menopause. The galvanic skin response can begraphed on a chart for observation, in the same way that heart or brainactivity is recorded.

In one embodiment of the system 1111, the galvanic response of the softtissue being treated is measured via a conductive sensor 14 to calculatea change in the galvanic response being brought about by the treatment.This change in galvanic response of the soft tissue being treated isused to determine if, and how, the electrical stimulation of thetreatment should be changed.

In one embodiment of the system 111, the system 111 includes electricalcontrol circuitry 300 that includes a high frequency oscillator and apower amplifier to generate a high frequency electrical signal that isthen delivered to a transducer, such as an electrode 14. The electricalenergy is then transmitted to the patient by applying a probe 13containing the electrode 14 against the patient's skin. The amplitude ofthe electrical signal is of interest in these electrical stimulationsystems because the lower the amplitude of the electrical signal, themore tolerant the patient is to the stimulation transmitted by theelectrode 14.

In one embodiment, the electrical stimulation involves placing theelectrode 14 on the skin and using various waveforms to stimulate atissue response, such as, for example, a muscle response in a passivemanner.

In one embodiment, the system 1111 will apply a pre load response tocompress the tissues during treatment. Pacinian corpuscles are pressurereceptors located in the skin and also in various internal organs. Eachpacinian corpuscle is connected to a sensory neuron. When pressure isapplied via the system probe 13, the pressure receptors elicit aresponse. However, the pressure receptors adapt very quickly andtherefore stop firing. With the system 1111, the pressure that isapplied via the probe 13 is augmented by the electrical stimulationprovided via the electrodes 14 so as to deter the adaptation andincrease the firing rate of the neural channel in addition to theelectrical stimulation.

In one embodiment, the system 1111 will also produce during treatment apressure wave that will stimulate motor neurons (e.g., type I-A) toactivate a stretch reflex response. Other areas of the nervous system,such as, for example, nerve roots and ganglia, are also consideredtargets for this therapy capable of being delivered via the system 1111.

To begin a more detailed discussion of the features, components andoperation of the system 1111, reference is made to FIG. 1, which is across-sectional side view of an impulse and sensing head 44. As shown inFIG. 1, the system 1111 for measurement of soft tissue mobility may beportable and hand-held and includes a delivery head 44 with an elongatedgenerally cylindrical housing 15 which has an insert 19 that tapers toform a generally conical configuration at the forward end 20. The otherend of the housing 15 is provided with a cylindrical closed end 21. Thehousing 15 and the closed end 21 may be separately connected by a screwthreaded connection to provide access into the interior of the housing15 and to separate the components of the invention for repair,replacement and the like. After housing 15 is unscrewed from closed end21, it can slide back and insert 19 can also be unscrewed from thehousing 15.

A probe 13 is located at the forward end 20 of the housing 15 andincludes cushioned tips 12 for contacting the soft tissue to bemeasured. The probe 13 may be constructed of a rigid material such asmetal, plastic, or the like. The probe 13 screws into or frictionallyinserts into the piezoelectric sensor 11. Different shaped probes 13 maybe used depending on if the apparatus is being used to measure softtissue or is being used for therapeutic purposes to improve soft tissue.Electrodes 14 may be supported on the probe 13, for example, at thecushioned tips 12, such that the electrodes 14 make good electricalcontact with the soft tissue when the probe is applied to the patient.

Within the housing 15 is a solenoid assembly 17. The assembly 17includes an electromagnetic coil 5 and an armature 7 longitudinallyreciprocally mounted without attachment within the coil 5. The armature7 is configured so that the end of the armature 7 will impact againstthe anvil 9 when the electromagnetic coil 5 is energized. The anvil 9 isaffixed to one side of a piezoelectric sensor 11. The impact produces aforce impulse which travels through the piezoelectric sensor 11 andcauses the piezoelectric sensor 11 to generate a wave form. When any oneof the various probes is placed against the soft tissue of a patient,the other end of the probe 13 resides firmly against the piezoelectricsensor 11 which in turn resides firmly against the anvil 9. A pressuresensor 3 that resides within the housing 15 is interposed between theclosed end 21 of the housing 15 and the solenoid 17. The pressure sensor3, works in concert with each of the other components so that uponreaching a point that corresponds to a predetermined pressure againstthe soft tissue of a human subject, the pressure sensor 3 causes therelease of a burst of current that energizes the electromagnetic coil 5such that the armature 7 is accelerated to impact with the anvil 9. Thepressure sensor may be comprised of a load cell. The impact of saidarmature 7 against the anvil 9 produces a force impulse which travelsdirectionally, in a continuum with the direction of the armature 7 atimpact, through the piezoelectric sensor 11 while at the same time beinginfluenced by the resistance placed upon the piezoelectric sensor 11 bythe probe 13 which is contact with the patient. The kinetic energy atthe point of impact causes the piezoelectric sensor 11 to emit anelectronic wave form which is characteristic of all of the elements ofthe electromechanical system on one side of the sensor opposed by all ofthe human elements on the other side of the sensor. The wave form iscaptured by data acquisition circuitry within a computer portion 45 ofthe system 1111 and retained therein for wave form analysis by theapplication of certain algorithms. Preferably, the power supply 41 is inthe computer portion 45 of the system 1111 or even in the CPU 34. Aninsulated cable 46 connects the delivery head 44 to computer portion 45of the system 1111 and the power supply 41. Alternatively, the currentmay be supplied through an electrical cord that may be plugged into asuitable electrical outlet or the like which extends into the housing15.

The mass of the armature 7 is substantially equal to the mass of theanvil 9 so that when the armature 7 strikes the anvil 9 it transfers theenergy of the armature 7 to the patient through the cushioned probe 13.The initial positions of the coil and the probe 13 are fixed so that theenergy of the system can only be varied by varying velocity of thearmature 7 at the point of impact with the anvil 9. The velocity of thearmature 7 can be varied by varying the force with which it isaccelerated into the electromagnetic coil 5 which is proportional to thecurrent flowing into the coils of the solenoid 17 which in turn isproportional to the voltage. The triggering point at which the solenoid17 is actuated can be varied by the relative movement pressure of thehousing 15 inwardly in relation to the solenoid 17 and the probe 13 sothat when the preset pressure has been matched, an electrical circuit iscompleted to the electromagnetic coil 5.

A single, or preferably, multi-axis inclinometer, disposed within thehead 44, will sense the angle of incidence of the probe 13 in contactwith the soft tissue being tested simultaneously with the formation ofthe wave form. The inclinometer 1 is connected by hard-wiring ortelemetry to the data acquisition circuitry of the computer portion 45of the system 1111. A signal corresponding to the angle of incidencewill be captured by the data acquisition circuitry of the computerportion 45 and retained for display on the computer screen 36.

As indicated in FIG. 1, the system includes an electrical stimulationunit 100, which employs a high frequency oscillator 105 and a poweramplifier 110 to generate a high frequency electrical signal that isthen delivered to a transducer, such as an electrode 14 electricallycoupled to the electrical stimulation unit 100. The electrical energy isthen transmitted to the patient by applying a probe contact supportedelectrode 14 against the patient's skin. In one embodiment, theelectrical stimulation unit 100 is subject to a control sequence orsoftware that causes the delivery of a continuous current or pulsecurrent via the electrodes 14 to the soft tissue at generally the sameinstant the force impulse is delivered to the soft tissue via the probe13.

In the one embodiment, the system 1111 herein described may be used fortherapeutic as well as analytical applications. For example, after ananalysis is completed, a health care practitioner may use oscillatingpercussion for treatment of soft tissue. This may be accomplished byrepetitively accelerating the said armature 7 to impact the anvil 9thereby causing the probe 13 to oscillate. The percussive force of theprobe 13 should be applied to a soft tissue for the purpose ofimproving/reducing muscle spasm and/or resetting the firing pattern ofthe muscle spindle fiber as well as exciting neural pathways. This maybe done at a controlled impulse frequency of repetitive force impulsesat a predetermined time period or a time period selected by the computeras a result of software algorithms. In the preferred embodiment, thefrequency of percussion is varied between 4 and 12 Hertz in incrementsof 0.1 Hertz. Because there is an inclinometer 1 within the therapydelivery head 44, precise angles of therapy may be applied to thepatient and documented for future reference. X-ray imaging or othermedical imaging may also be used in conjunction with the system 1111herein described for accurate estimation of the angle of incidence fortherapeutic purposes.

The treatment of the soft tissue provided by the oscillating percussiontreatment may be enhanced by the simultaneous delivery of electricity tothe soft tissue. For example, the electricity may be caused to beadministered continuously to the soft tissue over the course of theoscillating percussion treatment. Alternatively, the electricity may becaused to be administered to the soft tissue intermittently in such amanner that the electricity delivery is pulsed to coincide with eachpulse of the oscillating percussion treatment. Alternatively, theelectricity may be caused to be administered to the soft tissueintermittently in such a manner that the electricity delivery is pulsedto generally occur between the pulses of the oscillating percussiontreatment. Also, the electricity may be administered before or after thepercussive treatment.

Data characteristic of the angle of incidence, pressure of the probe 13on the patient, the force impulse via the probe 13, and the electricalimpulses delivered to the soft tissue via the electrodes 14 arepermanently stored in computer memory 37 for each area of soft tissuetested, inclusive of all of the tests performed on a given patientduring a given session so that such information may be combined with thetest interpretation as derived from the analysis of the elicited waveform for each soft tissue region tested. A basis or “base line” isprovided for comparison to the test angle of incidence so that thosetest angles can be matched during the performance of additional testing.The stored angle of incidence information along with the test dataanalysis for each patient session can be recalled and printed. Any partor, if practical, all of the test history of any patient can be combinedfor inclusion on one or more computer media so as to enable transfer ofthe records to any other practitioner so equipped to use the informationin the furtherance of the care of the patient. Because the test angle isrecorded and permanently stored, another doctor giving a second opinioncan use the same angle for testing. Therefore, the results of testsperformed by different doctors will be more uniform.

FIG. 2 is a block diagram of the architecture of the computer portion 45and piezoelectric impulse and sensing head 44 that form the system 1111.In one embodiment, the computer portion 45 of the system includes a CPU34, a monitor 36, memory 37, software code 38, a computer interface 40and hardware control circuitry 42. The electromechanical impulse andsensing head 44 is activated and controlled with the computer softwarecode 38 written onto the CPU 34 that communicates through the interface40 to hardware control circuitry 42 and to the impulse and sensing head44. Signals from the sensors 11 within the impulse and sensing head 44travel to the hardware control circuitry 42 for conditioning andtransmittal through the computer interface 40 circuitry to the CPU 34.Software code 38 is used to control and direct all signals between theelectromechanical component 44 and the computer portion 45. All relevantinformation generated by the processes of the system 1111 and used forthe processes of the system 1111 are stored in a memory 37 incommunication with the CPU 34. The relevant information may be recalledonto the monitor 36 or printed as required.

Similar to the electromechanical impulse and sensing head 44, theelectrodes 14 are energized and controlled with computer software code38 written onto the CPU 34 that communicates through the interface 40 tohardware control circuitry 42 and to the electrodes 14 and theelectrical stimulation unit 100. Signals from the sensors 11 within theimpulse and sensing head 44, from the electrodes 14 and/or from thecomponents of the electrical stimulation unit 100 travel to the hardwarecontrol circuitry 42 for conditioning and transmittal through thecomputer interface 40 circuitry to the CPU 34. Software code 38 is usedto control and direct all such signals between the aforementionedcomponents of the delivery head 44 and the computer portion 45 of thesystem 1111. All relevant information generated by the process is storedand may be recalled onto the monitor 36 or printed as required.

The resulting wave form is sinusoidal and will be influenced by suchthings as tissue mobility or resistance to mobility, fascia tension,muscle tonicity, connective tissue resiliency or inertia, local edema,and etc. Each such wave form may be characterized mathematically bylogging the peak amplitude, peak time, rise time, fall time, and slewrate. The mathematic values of the data logged will facilitate thecalculation of frequency response and certain ratios that willmathematically define the wave form characteristics. By analyzing themathematics of the wave form characteristics, certain assumptions can bemade as to the functional characteristics of the tissue condition.

As the data are collected and logged and after all of the pertinentmathematic calculations are made, a graphic display of the wave form maybe presented on a display device, such as, e.g., a computer monitor 36.In addition to the graphic display, the pertinent data and derivedratios may be displayed for assessment by the user of the equipment. Theuser will be one trained in the interpretation of the wave form shapeand interpretation of the logged and derived mathematic information. Thegraphic displays plus all of the mathematic information as a result ofsoft tissue percussion testing and/or electrical stimulation may bestored and recalled whenever deemed necessary. As the data base growsand expands, clinical assumptions will yield to statistically validprobabilities and predictive diagnoses. A permanent record of each testof each patient may be stored and recalled as necessary. It may also becopied to electronic storage media, such as, for example, a computerthumb drive, so that it can be transferred to another computer.

As each wave form is recovered from the piezoelectric sensor 11, severalthings become apparent. The amplitude of the wave form is of interestbecause as soft tissue resistance increases, the test wave formamplitude increases. Therefore, in FIG. 3 a simple bar chart 67 is usedfor the expression of wave form peak amplitude. A statistical analysis(mean and standard deviation) of the amplitudes is included. Standarddeviation may be set at one, two or three sigma and is expressed by ahorizontal line on bar chart 69. The shape of the wave is an interestingpiece of information. The expression of a ½ wave form 71 in a graphicdisplay of the wave form shape for all soft tissue regions. A compositeof all 7 Cervical, 12 Thoracic, or 10 Lumbosacral wave forms 73 isexpressed before treatment and after treatment.

Each of the wave forms represented on FIG. 3 and FIG. 4 are analyzed forPeak Amplitude, Peak Time, Rise Time, Fall Time, Frequency (Hertz), Time(%) to Peak and Area (%) to Peak. The derived information is displayedas shown on FIG. 7 along with some calculated factors that are alsoshown. From the information derived and calculated, a summary table, inFIG. 8, showing all of the derived values may be produced. From the dataon FIG. 8, charts may be produced so that the data may be presented inan informational format for comparisons. A sample of these charts isshown as FIGS. 9 through 12. Normal values can be compiled and chartedand used to determine normal versus aberrant soft tissue and forcomparison to the pre-treatment and post-treatment charts.

Using the information presented as herein described, a practitioner maydetermine treatment protocol and track progress with objectivity. Thepractitioner may calculate the resonant frequency of the soft tissueregion as a result of the wave form duration in milliseconds and use analgorithm to calculate a harmonic frequency that would be used duringpatient therapy to control the oscillating percussion used for softtissue treatment. A history of patient analysis and treatment may becompiled and used for discussion of patient's condition and progress aswell as justification for continuing treatment and rehabilitation.Results of rehabilitation may also be used for demonstration of patientcooperation and compliance to a prescribed exercise and rehabilitationprogram.

As can be understood from the preceding discussion, the system isconfigured to treat soft tissue via electrical stimulation inconjunction with the application of a simultaneous percussive force. Thesystem includes hardware and software used to deliver, control, andmonitor percussive force treatment and electrical stimulation treatmentto soft tissue. The controlling and monitoring of the percussive forceand electrical stimulation treatment is accomplished via software 38interfaced with a user via a computer interface 40.

As shown in FIG. 13, which is a diagrammatic depiction of an embodimentof the system 1111, the system 1111 includes the components describedabove with respect to FIGS. 1 and 2, except the hardware controlcircuitry 42 also includes an EStim control circuitry module 300 and ashockwave control module 305. The EStim control circuitry module 300 ishardwired to the EStim electrodes 14 via cable 310. The electrodes 14may be on the tips 12 of a dual tip probe 13, as shown at arrow A inFIG. 13. Alternatively, the electrodes 14 may be located on an EStim pad315 that can be adhered to patient skin and a single tip probe 13, asindicated at arrow B in FIG. 13.

The cable 46 depicted in FIG. 13 electrically couples the shockwavecontrol circuitry module 305 to the components of the delivery head 44as described above with respect to FIGS. 1 and 2.

In one embodiment, as can be understood from FIGS. 1, 2, 13 and 14,which is a flow chart illustrative of the operation of the system 1111,an anatomical representation of a patient is displayed on the touchscreen 500 of the monitor 36, and the operator selects a tissuetreatment region on the anatomical representation by touching the screen500, the selected tissue treatment region being stored in computermemory 37 [block 1000]. A preload tissue compression force may beselected [block 1005]. The tips 12 of the probe 13 are brought intopressed contact with the target tissue region and the preload tissuecompression force is applied to the target tissue region by causing thearmature 7 to impact the anvil 9, thereby accelerating the probe 13 intothe target tissue [block 1010]. The tissue signal resulting from theapplied preload tissue compression force is read via the piezoelectricsensor 11 in the sensing head 44 and analyzed and stored [block 1010].With the probe tips 12 contacting the target tissue region in a mannerthat places the electrodes 14 in electrical contact with the targettissue region, the galvanic response of the target tissue region is readvia the electrodes 14 and associated hardware and software and stored[block 1015]. A type of electrical stimulation is selected with respectto power and type of waveform [block 1020]. A mode of application of theelectrical stimulation with respect to continuous current or pulsedcurrent is selected [block 1025]. A mode of application of thepercussive impact treatment is selected [block 1030]. The percussiveimpact treatment and electrical stimulation treatment may be selectedfrom a plurality of predefined treatment protocols.

In one embodiment, the selected percussive impact treatment and selectedelectrical stimulation treatment are applied simultaneously to thetarget tissue region via the probe 13 and electrodes 14, respectively[block 1035]. Alternatively, in other embodiments, while the electricalstimulation treatment and percussive impact treatment may be appliedover the same treatment period, the delivery of the electricalstimulation and percussive impacts may be alternated back and forth suchthat the two types of treatment do not occur simultaneously.

The percussive delivery head 44 is used to measure the soft tissuecharacteristics of the target tissue region by use of piezoelectricsensors 11 to calculate a frequency of percussion impulses based on thesoft tissue response [block 1040]. The electrodes 14 are used to monitorthe application of, and the response to, the electrical stimulationduring treatment [block 1045]. The application of the electricalstimulation can be modified based on data obtained from operations ofblock 1045. In one embodiment, the operation of the system 1111 mayfurther continue wherein the galvanic response of the target tissueregion is read post treatment via the electrodes 14 and associatedhardware and software and stored and compared to the pretreatmentgalvanic response taken in block 1015 [block 1050]. The two storedgalvanic responses and the difference between the two are displayed viathe user interface [block 1055]. A change in soft tissue characteristicscan be determined from the change in galvanic response and/or thedifference in soft tissue characteristics determined via thepiezoelectric sensors 11 [block 1060].

FIG. 15 is a flow chart illustrating a methodology for selecting anelectrical stimulation protocol based off of a measured tissuecharacteristic (e.g., frequency) of percussive impulses. The selectionof the electrical stimulation protocol can occur during the course ofthe target tissue receiving treatment in the form of percussive impulse,the electrical stimulation protocol selection methodology being usedto: 1) justify continuing to maintain the electrical stimulationprotocol already being administered along with treatment; or 2) changethe electrical stimulation protocol already being administered alongwith the treatment to another electrical stimulation protocol.

As can be understood from FIG. 15, in one embodiment, percussive forcesare applied to the target tissue via the probe 13 [block 1500]. Thepiezoelectric sensor 11 is used to measure a frequency of the percussiveimpulses based on the soft tissue response [block 1505]. Characteristicsof the soft tissue are determined from the measured frequency [block1510]. The determined characteristics are used to determine anappropriate electrical stimulation [block 1515]. While the treatmentpressure is applied via the probe 13, the electrical stimulationdelivered via the electrodes 14 is modified according to the determinedappropriate electrical stimulation [block 1520].

FIG. 16 is a diagrammatic depiction of a database or library 200 thatexists in the memory 37 for use with the methodology discussed abovewith respect to FIG. 15. As shown in FIG. 16, the library 200 includesspecific frequencies or frequency ranges 205 (e.g., HZ1-HZ5) stored in acorrelated manner with respective specific corresponding tissuecharacteristics 210 (e.g., TC1-TC5). The specific tissue characteristics210 (e.g., TC1-TC5) are also stored in the library 200 in a correlatedmanner with respective specific electrical stimulation treatmentprotocols 215 (ES1-ES5).

As can be understood from FIGS. 15 and 16, percussive forces are appliedto the target tissue via the probe 13 per block 1500 and a resultingtissue frequency is measured per block 1505. Per block 1510, themeasured tissue frequency is compared to the frequency ranges 205 in thelibrary 200 and, for the sake of this example, the measured tissuefrequency falls within frequency range HZ3, which correlates with tissuecharacteristic TC3. Per block 1515, the determined tissue characteristicTC3 allows a corresponding electrical stimulation protocol 215 to bedetermined, which in this example, will be electrical stimulation ES3.Per block 1520, the ES3 electrical stimulation protocol is applied tothe tissue, which may: 1) simply result in the ES3 electricalstimulation protocol being applied with the percussive impulses being,or yet to be, applied; or 2) cause the electrical stimulation currentlybeing applied with the currently being applied percussive impulses tochange to the new ES3 electrical stimulation protocol determined inblock 1515.

While the embodiment discussed with respect to FIGS. 15 and 16 is givenin the context of the analyzed characteristic of the waveform being thefrequency of the waveform, in other cases the analyzed characteristic ofthe shockwave waveform may be its amplitude, wave shape, or anyone ormore of its frequency, amplitude or wave shape.

FIG. 17 is a flow chart illustrating a methodology of selecting anelectrical stimulation protocol based off of a measured galvanicresponse. The selection of the electrical stimulation protocol can occurduring the course of the target tissue receiving treatment in the formof electrical stimulation and/or percussive impulse, the electricalstimulation protocol selection methodology being used to: 1) justifycontinuing to maintain the electrical stimulation protocol already beingadministered along with the treatment; or 2) change the electricalstimulation protocol already being administered along with the treatmentto another electrical stimulation protocol.

As can be understood from FIG. 17, in one embodiment, treatment in theform of electrical stimulation and/or percussive impulses is applied tothe target tissue via electrodes 14 and/or the probe 13, respectively[block 1550]. Acting as a conductive sensor, the electrodes 14 are usedto measure a first galvanic response of the target tissue at an initialpoint in time in the treatment, the first galvanic response being inresponse to the treatment of block 1550 [block 1555]. Again acting as aconductive sensor, the electrodes 14 are used to measure a secondgalvanic response of the target tissue at a subsequent point in time inthe treatment, the second galvanic response being in response to thetreatment of block 1550 [block 1560].

The first and second galvanic responses are compared to determine adifference in galvanic response [block 1565]. Characteristics of thesoft tissue are determined from the determined difference in galvanicresponse [block 1570]. The determined characteristics are used todetermine an appropriate electrical stimulation [block 1575]. While thetreatment being is applied via the electrodes 14 and/or probe 13, theelectrical stimulation delivered via the electrodes 14 is modifiedaccording to the determined appropriate electrical stimulation [block1580].

FIG. 18 is a diagrammatic depiction of another database or library 201that exists in the memory 37 for use with the methodology discussedabove with respect to FIG. 17. As shown in FIG. 18, the library 201includes specific galvanic response differences or galvanic responsedifference ranges 220 (e.g., GR1-GR5) stored in a correlated manner withrespective specific corresponding tissue characteristics 210 (e.g.,TC1-TC5). The specific tissue characteristics 210 (e.g., TC1-TC5) arealso stored in the library 201 in a correlated manner with respectivespecific electrical stimulation treatment protocols 215 (ES1-ES5).

As can be understood from FIGS. 17 and 18, treatment in the form ofelectrical stimulation and/or percussive impulses is applied to thetarget tissue via the electrodes 14 and/or probe 13 per block 1550, anda first galvanic response is measured per block 1555. The treatmentcontinues, and a second galvanic response is measured per block 1560.Per block 1565, the first and second galvanic responses are compared todetermine a galvanic response difference, Per block 1570, the determinedgalvanic response difference is compared to the galvanic responsedifference ranges 220 in the library 201 and for the sake of thisexample, the determined galvanic response difference falls withingalvanic response difference ranges GR4, which correlates with tissuecharacteristic TC4. Per block 1575, the determined tissue characteristicTC4 allows a corresponding electrical stimulation protocol 215 to bedetermined, which in this example, will be electrical stimulation ES4.Per block 1580, the ES4 electrical stimulation protocol is applied tothe tissue, which may: 1) simply result in the ES4 electricalstimulation protocol being applied with the treatment being, or yet tobe, applied; or 2) cause the electrical stimulation currently beingapplied with the currently being applied treatment to change to the newES4 electrical stimulation protocol determined in block 1575.

In some embodiments, the methodology discussed above with respect toFIGS. 17 and 18 is implemented via a system 1111 as shown in FIGS. 2 and13, wherein the system 1111 includes software 38 and hardware (e.g.,electrodes 14, CPU 34, memory 37, computer interface 40, hardwarecontrol circuitry 42, conductive cables 46, 215, etc.) that allows forthe measurement of a galvanic response of target tissue before, duringand/or after a treatment (e.g., electrical stimulation and/or percussiveimpulse) is applied to the target tissue. Also, the system 1111 as shownin FIGS. 2 and 13 includes software 38 and hardware (e.g., monitor 36,etc.) that allows the pre and post galvanic response to be displayedboth before and after treatment.

As can be understood from FIGS. 2 and 13, the system 1111 includes amonitor 36 with a touch screen interface 500 that allows an operator toselect treatment protocols and set treatment parameters. The touchscreen 500 displays different screen display arrangements. For example,a treatment display screen, which functions according to the method flowchart depicted in FIG. 19, may be displayed on the touch screen 500.

As can be understood from FIG. 19, the operator elects to utilizeelectrical stimulation as part of the treatment of the patient with thesystem 1111. The operator presses an EStim initialization button on thetouch screen 500 [block 2000] and the system 1111 determines if theEStim capability is active or not [block 2005]. If the EStim capabilityis not active, the system 1111 displays an EStim setup displayarrangement on the touch screen 500 of the monitor 36 [block 2010].Alternatively, as indicated at arrow A in FIG. 19, the operator cansimply “double click” the EStim initialization button to cause thedisplay of the EStim setup screen.

FIG. 20 illustrates an example of such an EStim setup displayarrangement on the touch screen 500 of the monitor 36. The EStim setupdisplay arrangement shown on the touch screen 500 includes an “EStim”status indicator 505, a mode button 510, a waveform button 515, a tip orprobe-type indication 520, a tip or probe type selection button 525, an“Apply” button 530, a “Reset” button 535, a “Cancel EStim” button 540, atime button 545, an output current selector 550, an output voltageselector 555, an EStim length selector 560, and an Output Frequencyselector 561. The EStim status indicator 505 conveys to the operatorwhether or not the electrical simulation capability of the system 1111is active (e.g., ready for use) or not.

The mode button 510 allows for the operator to select from a variety ofoperational modes. For example, as illustrated in FIG. 21, which is thesame view as FIG. 20, except showing a pull down menu 565 activated viathe mode button 510, in one embodiment, the selectable modes include: 1)analyze tissue impulse frequency and/or tissue response (e.g., galvanicresponse) followed by application of electrical stimulation to tissue(Analysis->EStim); 2) analyze tissue impulse frequency and/or tissuegalvanic response followed by application of electrical stimulation totissue followed by application of force impulse to tissue(Analysis->EStim->Adjust); 3) analyze tissue impulse frequency and/ortissue galvanic response followed by application of force impulse totissue followed by application of electrical stimulation to tissue(Analysis->Adjust->EStim); 4) application of electrical stimulation totissue followed by application of force impulse to tissue(EStim->Adjust); and 5) application of electrical stimulation to tissue(EStim only).

The waveform button 515 allows for the operator to select from a varietyof waveforms for the electrical stimulation. For example, as illustratedin FIG. 22, which is the same view as FIG. 20, except showing a pulldown menu 571 activated via the waveform button 515, in one embodiment,the selectable waveforms include: 1) auto, which allows the system toautomatically select an appropriate waveform based off of the system'sanalysis of percussive impulse tissue readings and/or galvanic responsetissue readings; 2) hi voltage mono-phasic; 3) hi voltage bi-phasic; 4)Russian symmetrical bi-phasic; 5) square wave mono-phasic; and 6) squarewave bi-phasic.

The tip or probe type selection button 525 can be used to toggle thesystem 1111 between the variety of probe-types that can be employed withthe system, as indicated in FIGS. 25A-25J, which illustrates a varietyof types of probes 13 that are configured for interchangeable use withthe system 1111 and are described in detail below. As can be understoodfrom FIG. 20, the tip or probe-type indication 520 depicts a graphicalrepresentation of the probe-type selected via the probe type selectionbutton 525.

The time button 545 can be used to set the duration of the electricalstimulation. In some embodiments, the time button 545 will also act as adisplay that displays the time remaining until the end of the electricalstimulation.

The output current selector 550 can be used to set the output current ina range of 0-25 mA. The initial current setting may depend on theprobe-type selected via button 525, the waveform selected via button515, and the treatment target location on the patient's body. In oneembodiment, the current setting may be automatically set according totreatment parameters stored in the memory 37, the treatment parametersbeing specific to respective combinations of probe-type, waveform andtreatment target location.

The output voltage selector 555 can be used to set the output voltage ina range of 0-10 V. The initial voltage setting may depend on theprobe-type selected via button 525, the waveform selected via button515, and the treatment target location on the patient's body. In oneembodiment, the voltage setting may be automatically set according totreatment parameters stored in the memory 37, the treatment parametersbeing specific to respective combinations of probe-type, waveform andtreatment target location.

The EStim length selector 560 can be used to set the electricalstimulation from 1-61 pulses over the duration selected via the timebutton 545, wherein a setting of zero equals a single pulse and asetting of 60 equals 61 pulses.

The Output Frequency selector 561 can be used to set the electricalstimulation from 0.1-150 Hz. The initial frequency setting may depend onthe probe-type selected via button 525, the waveform selected via button515, and the treatment target location on the patient's body. In oneembodiment, the frequency setting may be automatically set according totreatment parameters stored in the memory 37, the treatment parametersbeing specific to respective combinations of probe-type, waveform andtreatment target location.

Once all of the settings for the system 1111 are set via the settingcontrols 510, 515, 525, 550, 555, 560 and 561 as described above, theoperator can actuate the “Apply” button 530 to cause the system 1111 toadopt the settings and cause the “EStim” status indicator 505 to changefrom “Not Active” to “Active” and the computer interface 40 to return tothe treatment screen display. Actuating the “Apply” button 530 alsocauses the system 1111 to instruct the operator via the monitor 36regarding any setup required for the system 1111 to function as neededfor the adopted settings. For example, upon actuating the “Apply” button530, the system 1111 may prompt the operator via the monitor 36 tocouple a specific type of probe 13 and/or EStim pad 315 to the system1111. Also, actuation of the “Apply” button 530 may cause the system1111 via the monitor 36 to provide safety and/or treatment instructionsto the operator.

The “Reset” button 535 can be actuated by the operator to reset thesetting controls 510, 515, 525, 550, 555, 560 and 561 to modify theelectrical stimulation to be provided via the system 1111.

As can be understood from FIG. 19, the operator can actuate the “CancelEStim” button 540 shown in FIG. 20 [block 2015], which clears theelectrical stimulation settings and deactivates the electricalstimulation [block 2020], thereby causing the “EStim” status indicator505 to change from “Active” to “Not Active”. The system 1111 then goesto the shockwave treatment mode [block 2025] shown in FIGS. 23 and 24.

As can be understood from FIG. 19, if it is determined at block 2005that the EStim is active, then the system 1111 deactivates the EStimsubsystem [block 2020] and the system 1111 system transitions to theshockwave treatment mode [block 2025] shown in FIGS. 23 and 24.

As can be understood from FIG. 23, the tips 12 of the treatment head orprobe 13 are pressed against the treatment target tissue of the patientuntil the preload threshold is met as discussed in detail above [2030].The system 1111 does another check to see if the EStim is active [block2035]. If the EStim is active, then the EStim subsystem is deactivated[block 2040], and the shockwave is then applied [block 2045]. If theEStim check of block 2035 shows that the EStim is already not active,then the shockwave is then applied [block 2045].

Continuing the process in FIG. 24, the target tissue frequency responseis read via the piezoelectric sensor 11 and processed [block 2050]. Datapertaining to the target tissue frequency response to the shockwave isdisplayed on the monitor 34 or its treatment screen 500 [block 2055].The system 1111 again checks to see if the EStim is active [block 2060]and, if not, then the EStim setup display arrangement (shown in FIG. 20)is displayed on the touch screen 500 of the monitor 36 [block 2065],thereby allowing the EStim settings to be set as described above and theEStim to be activated [block 2070].

As can be understood from FIG. 24, regardless of whether the check ofblock 2060 indicated that the EStim was already active or the EStim wasactivated at block 270, the system does a check to see if the EStim modeis set to auto [block 275]. If the EStim is not active, the systemdisplays EStim setup display arrangement on touch screen of computerinterface at block 265, and then the EStim is activated at block 270. Ifthe EStim mode is set to auto, then the system 1111 applies the EStimaccording to the system's analysis of the shockwave data, applying EStimprotocols and parameters as stored in the memory 37 and determined bythe system 1111 to be appropriate for the target tissue based on thesystem's analysis of the shockwave data [block 280]. The auto EStim isthen applied to the patient's treatment target tissue [block 285]. Ifthe check of block 275 reveals the EStim mode is not set to auto, thenthe EStim is applied [block 285] and the EStim in this case will beapplied per the protocols and parameters manually set via the EStimsetup display arrangement (shown in FIG. 20) displayed on the touchscreen 500 of the monitor 36.

As can be understood from FIGS. 25A-25J, a variety of differentconfigurations of probes 13 can be employed with the therapy deliveryhead 44 of FIGS. 1, 2 and 13. For example, as illustrated in FIGS.25A-25C and 25E-25G, the probe 13 can have a generally horseshoe-shapedbody ending is two space-apart tips 12, which may be soft. A stem 570extends from the opposite side of the body of the probe 13 from the tips12, the stem 570 being used for coupling the probe 13 to the forward end20 of the head 44 and the piezoelectric sensor 11 and anvil 9, as can beunderstood from FIG. 1. Each tip 12 may have an electrode 14 at theextreme end of the tip 12.

As indicated in FIGS. 25A-25C and 25G, some dual tipped probes 13 mayhave tips 12 that extend generally an even distance. As shown in FIGS.25E and 25F, other dual tipped probes 13 may have tips 12 that do notextend an even distance.

As can be understood from FIGS. 25A-25C and 25E-25G, the dual tippedprobes 13 may have tips 12 that are laterally spaced apart from eachother a variety of distances W. For example, the dual tipped probes 13of FIGS. 25A-25C and 25E-25G have respective tip spacing distances W of3.2 cm, 4.7 cm, 2.2 cm, 3.2 cm, 3.2 cm and 9.8 cm. As can be understoodfrom a comparison of FIGS. 25E and 25F, despite having the same spacingdistances W of 3.2 cm, the dual tipped probe 13 of FIG. 25F has agreater difference in the extent of extension of its tips 12 relative toeach other than is the case with the tips 12 of the probe of FIG. 25E.

As can be understood from FIGS. 25D and 25H-25J, some embodiments of theprobe 13 may have a single tip 12. A stem 570 extends from the oppositeside of the body of the probe 13 from the tip 12, the stem 570 beingused for coupling the probe 13 to the forward end 20 of the head 44 andthe piezoelectric sensor 11 and anvil 9, as can be understood fromFIG. 1. The tip 12 may have an electrode 14 at the extreme end of thetip 12.

In some cases, as in FIG. 25D, the single tip 12 may be generallyhemispherical in configuration. In other cases, as in FIGS. 25H-25J, thesingle tip 12 may be generally flat-ended in configuration.

As can be understood from FIGS. 25H-25J, the flat-ended tips 12 may havea variety of widths W. For example, the flat-ended tips 12 depicted inFIGS. 25H-25J have respective widths W of 4.5 cm, 3.2 cm, and 1.7 cm.Such flat-ended tips 12 may be formed of soft rubber.

In some instances, the probes 13 of FIGS. 25A-25D may be employed wherethe patient tissue that is the target of the treatment being provide viathe system 1111 is adjacent the patient's vertebra. The probes 13 ofFIGS. 25E-25G may be employed on specific anatomical features of thepatient. The probes 13 of FIGS. 25H-25J may be employed where the tissuebeing treated is in close proximity to skeletal structures.

For a discussion of an alternative embodiment of the system of FIG. 13,reference is made to FIG. 26, which is a flow chart illustrating anotheroperational methodology for the system 1111 and its touch screeninterface 500. As shown in FIG. 26, a start screen 2600 may be displayedwherein the start screen 2600 displays a start button 2602, a settingsbutton 2604, a history button 2606, and an exit button 2608. Uponpressing the start button 2602, the system 1111 enters a select patientmode 2610. As a result, where the patient currently being treated viathe system 1111 is a patient previously treated via the system 1111, theselect patient mode 2610 allows the operator of the system 1111 toselect the patient's name to cause the patient's previously storedmedical data and associated system operational settings to automaticallyload and be usable by the system 1111 for the current treatment of thepatient. Alternatively, where the patient currently being treated viathe system 1111 is a new patient never previously treated via the system1111, the select patient mode 2610 allows the operator of the system1111 to enter new patient's name and patient data for use by the system1111 for the treatment of the new patient. Once the operator hasselected the patient name or entered the name and data of a new patient,the operator can press the OK button 2612 to close out of the selectpatient mode 2610. The system 1111 then displays on the touch screeninterface 500 the analysis screen 2614.

Upon pressing the settings button 2604, the system 1111 enters asettings screen mode 2616, which displays the systemdiagnostic/treatment settings currently set for the patient selected viathe select patient mode 2610. The operator can adjust the systemdiagnostic/treatment settings via the settings screen mode 2616. Thesystem diagnostic/treatment settings can be saved and the settingsscreen mode 2616 can be exited by pressing the OK button 2618. Thesystem 1111 then displays on the touch screen interface 500 the startscreen 2600, unless an exit button 2619 is pressed, thereby causing thesystem 1111 to display on the touch screen interface 500 the analysisscreen 2614.

Upon pressing the history button 2606, the system 1111 enters a viewpatient history mode 2620, which displays the patientdiagnostic/treatment history for the patient selected via the selectpatient mode 2610. Once the operator is done reviewing the patienthistory, the view patient history mode 2620 can be exited by pressingthe OK button 2622. The system 1111 then displays on the touch screeninterface 500 the start screen 2600, unless the exit button 2619 ispressed, thereby causing the system 1111 to display on the touch screeninterface 500 the analysis screen 2614.

Upon pressing an exit button 2608 at the start screen 2600, an exitprogram mode 2624 will begin, thereby causing the system 1111 toautomatically shut down.

Still referring to FIG. 26, it can be understood that the probe 13 ofthe treatment head 44 is depressed against the treatment target locationon the patient [see 2630], which causes the system 1111 to process theresulting analog signal [see 2632]. As can be understood at 2634 in FIG.26, depending on whether the system 1111 is in the analysis mode and thehead depressing 2630 was for analysis purposes or the treatment mode andthe head depressing 2630 was for treatment purposes, the system willdisplay on the touch screen interface 500 the analysis screen 2614 or atreatment screen 2636. If the analysis screen 2614 is displayed, thenthe data from the processed analog signal [see 2632] will be displayedon the analysis screen [see 2638]. If the treatment screen 2636 isdisplayed, then the data from the processed analog signal [see 2632]will be displayed on the treatment screen [see 2640] and, a followingpress of the exit button 2642 will the system to then transition to theanalysis screen 2614.

When the treatment screen 2636 of FIG. 26 is displayed, the system 1111is in a treatment mode and can be caused to function as depicted in FIG.27. As shown in FIG. 27, if the probe 13 of the treatment head 44 ispressed against the patient [see 2700] and the preload threshold hasbeen met, the system 1111 will determine if the system 1111 is in atrigger point analysis mode [see 2702]. The trigger point analysis isused to perform a single point analysis to determine the characteristics(e.g., frequency, amplitude and/or wave shape) that trigger or treatmentpoint. If the system 1111 is not in the trigger point analysis mode,then the system 1111 will determine if the EStim is active [see 2704]and, if yes, then the system will apply the EStim per the EStim setupmode [see 2706], but the EStim will be delayed [see 2708] to be appliedwith the shockwave [see 2710]. If the trigger point analysis mode 2702is on, then the shockwave is applied [see 2710].

When the shockwave is applied as noted at 2710 in FIG. 27, a shockwavesubsystem data event may take place as now explained with respect toFIG. 28. Specifically, sensor data is read and processed [see 2800], andthe shockwave data is displayed on the treatment screen [see 2802]. Thesystem determines if the trigger point analysis mode is active [see2804] and, if not, the system 1111 returns to the treatment screen [see2806]. If the trigger point analysis mode [see 2804] is active, thensystem 1111 sets up the shockwave treatment based on the shockwave dataanalysis [see 2808]. The system 1111 determines if the EStim is active[see 2810] and, if no, then the system returns to the treatment screen[see 2812]. If the EStim is active [see 2810], then the system 1111determines if the EStim mode is set to auto [see 2814] and, if yes, thenthe EStim subsystem is set up based on the shockwave data analysis [see2816]. If the EStim mode is set to auto [see 2814] or the EStimsubsystem has already been based on the shockwave analysis [see 2816],then the EStim output is activated when the probe 13 of the treatmenthead 44 is pressed against the patient [see 2818] followed by a returnto the treatment screen [see 2820].

As can be understood from FIG. 29, in one embodiment, the EStimsubsystem can be setup based on a shockwave data analysis. Specifically,a waveform is generated from the shockwave administered via thetreatment head 44 [see 2900]. The system 1111 performs an analysis of acharacteristic of the waveform [see 2902]. For example, the systemanalyzes the frequency of the waveform. The resulting shockwavefrequency analysis parameters are used in accessing the EStim frequencydatabase to select an EStim frequency [see 2904]. The EStim frequencydatabase may include EStim frequencies and various associated setupparameters appropriate for a specific ranges of EStim frequencies. TheEStim subsystem is setup based on the shockwave data analysis [see2906]. The EStim output is caused to activate when the probe 13 of thetreatment head 44 is pressed against the patient [see 2908]. While theembodiment discussed with respect to FIG. 29 is given in the context ofthe analyzed characteristic of the waveform being the frequency of thewaveform, in other cases the analyzed characteristic of the shockwavewaveform may be its amplitude, wave shape, or anyone or more of itsfrequency, amplitude or wave shape.

Thus, as can be understood from FIGS. 13 and 29, in one embodiment, thesystem 1111 disclosed herein is for treating the soft tissue of apatient. The system includes a treatment head 44 and a computer portion45. The treatment head 44 includes a probe 13 and an electrode 14operably coupled to the probe. The probe and electrode are configured torespectively deliver a mechanical force impulse and an electricalstimulation to the soft tissue when placed in operable contact with thesoft tissue. The computer includes a CPU 34 and is configured tocoordinate the delivery of the mechanical force impulse and electricalstimulation relative to each other. The system 1111 is configured tosense a shockwave in the soft tissue of the patient, the shockwaveresulting from the mechanical force impulse delivered to the soft tissuevia the probe. The system 1111 is also configured to analyze acharacteristic of the sensed shockwave and configure the electricalstimulation to be delivered to the soft tissue via the electrode basedon the characteristic analysis of the sensed shockwave, thecharacteristic analyzed being at least one of the frequency, amplitudeor waveform of the sensed shockwave.

While the system 1111 may be configured to self-prescribe an electricalstimulation protocol based off of an analysis of a characteristic of thesensed shockwave as discussed above with respect to FIGS. 13, 15, 16 and29, in other embodiments, the system may be configured to self-prescribean electrical stimulation protocol based off of an identification of apatient affliction and inputting the identified patient affliction intothe system 1111 to allow the system to access a database whereinspecific electrical stimulation treatment protocols are referenced tospecific affliction diagnoses.

For example, as can be understood from FIG. 13 and the flow chartbeginning in FIG. 30, a medical professional, who is the operator of thesystem 1111, uses the touch screen 500 to select an EStim treatmentprotocol database [see 3000]. The operator diagnoses the patient via,for example, reference to the patient's medical records, physicalobservation, and/or medial tests and diagnostics. Once diagnosing thepatient's affliction, the operator uses the touch screen 500 to selectan affliction diagnosis from those available in the EStim protocoldatabase 3300, which is depicted in FIG. 33 [see 3002]. The EStimprotocol database 3300 may have a number of common affliction diagnoses3302 that are each referenced to a respective individually tailoredtreatment protocol 3304. For example, if the patient's diagnosiscorresponds to affliction diagnosis AD2, then the operator selectsaffliction diagnosis AD2 and the system 1111 loads correspondingtreatment protocol TP2 for administration to the patient. Examples ofaffliction diagnoses 3302 that may have respective predefined treatmentprotocols 3304 stored in the database 3300 include muscular dystrophy,multiple sclerosis, muscle atrophy due to stroke or paralysis,pre-operative surgical preparation, post-operative surgical recovery orphysical therapy, discopathy, or etc.

Thus, the memory 37 includes an electrical stimulation protocol database3300 containing multiple treatment protocols 3304 referenced torespective multiple affliction diagnoses 3302. In other words, each ofthe treatment protocols TP1-TP5 of the multiple treatment protocols 3304may be referenced to a respective affliction diagnosis AD1-AD5 of themultiple affliction diagnoses 3302. Each such affliction diagnosisAD1-AD5 of the multiple affliction diagnoses 3302 may have a treatmentprotocol TP1-TP5 with electrical characteristics that are unique ascompared to the electrical characteristics of the other treatmentprotocols TP1-TP5 of the multiple treatment protocols 3304.

If the operator cancels out of the selection of the affliction diagnosisat 3002, then the system 1111 returns to the treatment screen [see3004]. However, if the operator does make a selection of a specificaffliction diagnosis AD1-AD5 of the multiple available afflictiondiagnoses 3302 available in the database 3300 as indicated at 3002, thenthe system 1111 loads the specific corresponding treatment protocolTP1-TP5 out the multiple treatment protocols 3304 available in thedatabase 3300. The system 1111 then looks to see if the loaded treatmentprotocol has a defined waveform type [see 3006], and, if so, the systemsets the EStim up for the waveform [see 3008]. If not, then the systemprompts the operator to select a waveform types [see 3010]. Such aprompting may give directions to the operator on suggested waveformsthat might be appropriate based on desired outcome, perceived patientissues or needs, etc.

The system 1111 then looks to see if the loaded treatment protocol has adefined output voltage [see 3012], and, if so, the system sets the EStimup for the output voltage [see 3014]. If not, then the system promptsthe operator to select an output voltage [see 3016]. Such a promptingmay give directions to the operator on suggested voltages that might beappropriate based on desired outcome, perceived patient issues or needs,etc.

The system 1111 then looks to see if the loaded treatment protocol has adefined output current [see 3018], and, if so, the system sets the EStimup for the output current [see 3020]. If not, then the system promptsthe operator to select an output current [see 3022]. Such a promptingmay give directions to the operator on suggested currents that might beappropriate based on desired outcome, perceived patient issues or needs,etc.

As continued in FIG. 31, the system 1111 then looks to see if the loadedtreatment protocol has a defined output frequency [see 3100], and, ifso, the system sets the EStim up for the output frequency [see 3102]. Ifnot, then the system prompts the operator to select an output frequency[see 3104]. Such a prompting may give directions to the operator onsuggested frequencies that might be appropriate based on desiredoutcome, perceived patient issues or needs, etc.

The system 1111 then looks to see if the loaded treatment protocol has adefined output time [see 3106], and, if so, the system sets the EStim upfor the output time [see 3108]. If not, then the system prompts theoperator to select an output time [see 3110]. Such a prompting may givedirections to the operator on suggested output times that might beappropriate based on desired outcome, perceived patient issues or needs,etc.

The system 1111 then looks to see if the loaded treatment protocol has adefined number of pulses [see 3114], and, if so, the system sets theEStim up for the number of pulses [see 3116]. If not, then the systemprompts the operator to select a number of pulses [see 3118]. Such aprompting may give directions to the operator on suggested number ofpulses that might be appropriate based on desired outcome, perceivedpatient issues or needs, etc.

As continued in FIG. 32, the system 1111 then looks to see if the loadedtreatment protocol has defined operator instructions [see 3200], and, ifso, the system displays those instructions to the operator on themonitor 36 [see 3202], or if not, the system displays general ESTIMoperator instructions [see 3204]. Such instructions may includeelectrode placement on the patient, where to place probes on thepatient, patient preparations, system settings, etc. If not, then thedisplays general EStim operator instructions that are similar to thoseprovided in 3202, but not specific to the selected treatment protocol[see 3104]. The system 1111 then returns to the treatment screen 3206.

Preoperative and Postoperative Treatment Via System Disclosed Herein

In one embodiment, the system 1111 disclosed herein and depicted inFIGS. 1 and 2 may be employed for preoperative and postoperativetreatment (“PAPT”) of tissue associated with a surgical site. The system1111 is configured to guide the operator through pre-operative andpost-operative treatments of patient tissue associated with one or moresurgeries associated with one or more anatomical landmarks in accordancewith selected treatment protocols. In this aspect, PAPT protocols allowthe system 1111 to apply percussive impacts to tissues using the impulsestimulator instrument 44, those tissues, whether hard soft and/or hardtissues being associated with the preparation and/or recovery of thepatient tissue impacted by a surgical procedure. Other PAPT protocolsmay additionally or exclusively include electrical stimulation appliedto hard and/or soft tissues in associated with the surgical site. Theelectrical stimulation may be in the form of electrical stimulationprotocols described above.

The PAPT protocols implemented by the system 1111 can break up andprevent tissue adhesions and fixations and reduce pain and inflammationfollowing surgical procedures such as, for example, arthroplasty of thehip, knee and shoulder. Further, PAPT protocols implemented by thesystem 1111 can increase and improve tissue blood flow, lymphaticdrainage, osteogenic activity, range of motion (“ROM”), muscle strength,and joint kinesis and function. Also, the PAPT protocols implemented bythe system 1111 can reset muscle spindle fibers and stimulate neuralpathways (i.e., nerve root and receptors).

I. Tissue Treatment Application

FIG. 34 is a block diagram depicting a preoperative and postoperativetreatment tissue treatment application N120A executing on the dataacquisition circuitry 45 and the software code 38 depicted in FIG. 2.According to one aspect, the computing device 45 of FIG. 34 includes aprocessing system N202 that includes one or more processors or otherprocessing devices. The processing system N202 executes the preoperativeand postoperative treatment tissue treatment application N120A to selectand provide a treatment of the tissues of a patient associated with asurgical site using the impulse stimulator instrument 44 with or withoutthe available electrical stimulation. A database N122 may be accessed bythe tissue treatment application N120A during execution to provideinformation including, but not limited to: stored patient information,stored treatment protocols, and stored instrument control settings.

In an aspect, the computing device 45 includes a computer readablemedium (“CRM”) N204 configured with the tissue treatment applicationN120A. The tissue treatment application N120A includes instructions ormodules that are executable by the processing system N202 to enable auser to implement a treatment to the tissues of a patient.

The CRM N204 may include volatile media, nonvolatile media, removablemedia, non-removable media, and/or another available medium that can beaccessed by the computing device 45. By way of example and notlimitation, computer readable medium N204 comprises computer storagemedia and communication media. Computer storage media includesnontransient memory, volatile media, nonvolatile media, removable media,and/or non-removable media implemented in a method or technology forstorage of information, such as computer readable instructions, datastructures, program modules, or other data. Communication media mayembody computer readable instructions, data structures, program modules,or other data and include an information delivery media or system.

A GUI module N206 transmits one or more GUIs to the display. Theoperator of the system 1111 interacts with one or more GUIs receivedfrom the computing device 45 to review treatment protocols, enter dataand make menu selections used to implement a treatment using the system1111. Examples of screen shots of the one or more GUIs in variousaspects are provided herein below.

In an aspect, the tissue treatment application N120A includes atreatment protocol selection module N208 for selecting an appropriatetreatment protocol based on stored patient data, analysis of thepatient's tissues, selection from a stored menu of treatment protocols,and/or specification of a treatment protocol by the operator of thesystem 1111. The tissue treatment application N120A may further includemodules to implement a particular treatment on the tissues of a patient,such modules including, for example, a preoperative and postoperativetreatment (“PAPT”) module N218. A detailed description of the PAPTmodule N218 is provided herein below.

II. Treatment Protocol Selection Module

The treatment protocol selection module N208 selects one or moretreatment protocols to be performed on the tissues of a patient. The oneor more treatment protocols may be selected from a stored menu oftreatment protocols, a treatment protocol may be determined based on anassessment of the condition of the patient's tissues, or a treatmentprotocol may be specified by the operator of the system 1111. Thetreatment protocol selection module N208 in an embodiment may include astored treatment protocol module N210, and an operator-selectedtreatment module N214.

a. Stored Treatment Protocol Module

The stored treatment protocol module N210 is configured to generate amenu of treatment protocols from which the operator may select atreatment for the tissues of the patient, as well as to implement thetreatment protocol selected from the menu by the operator. In anembodiment, illustrated in FIG. 35, the stored treatment protocol moduleN210 may include a treatment protocol selection module N302, aninstrument control settings module N304, and a treatment selectionmodule N306. The treatment protocol selection module N302 generates amenu of treatment protocols and displays this menu to the operator viathe GUI. The menu of treatment protocols may be a list of standardtreatments arranged into one or more organizational schemes including,but not limited to: surgery type, region of patient body, type ofpatient tissue, type of tissue disorder, treatments previously performedon the patient, desired results of a tissue treatment, and a schedule ofplanned treatments for a patient. In an embodiment, the stored treatmentprotocol module N210 may access stored patient information from thedatabase in order to generate the menu of patient-specific treatmentprotocols. For example, the stored treatment protocol module N210 mayretrieve one or more patient-specific treatment protocols from thedatabase N122 for use in the menu of treatment protocols.

Referring back to FIG. 35, the stored treatment protocol module N208 mayfurther include an instrument control settings module N304 configured todetermine the appropriate settings for one or more instruments used toimplement a treatment protocol selected by the operator from the menu oftreatment protocols using the treatment protocol selection module N302.As illustrated in FIG. 2, the system 1111 may administer treatments withone or more instruments including, but not limited to, an impulsestimulator instrument 44 and/or an the electrodes 14 of the electricalstimulation system supported thereon. In an embodiment, the instrumentcontrol settings module N304 may determine one or control settings forthe impulse stimulator instrument 44 including, but not limited to,preload tissue compression force, magnitude and frequency of apercussive impact to be applied to the tissue. In another embodiment,the instrument control settings module N304 may determine one or controlsettings for the electrodes 14 of the electrical stimulation systemincluding, but not limited to: magnitude and frequency of an electricalstimulation to be applied to the tissue. A more detailed description ofadditional instrument control settings that may be determined by theinstrument control settings module N304 are provided herein below.

The stored treatment protocol module N208 may further include atreatment selection module N306. Once the treatment protocol has beendetermined by the treatment protocol selection module N302 and theinstrument control settings have been initialized by the instrumentcontrol settings module N304, the treatment selection module N306 mayinitiate the execution of one or more of the treatment modules used toimplement a treatment on a tissue associated with a surgical site.

FIG. 36 is a flow chart illustrating method N210A including a series ofactions taken by the operator of the system 1111 in an embodiment of thestored treatment protocol module N208. In this embodiment, the operatorof the system 1111 makes a selection to access the stored treatmentprotocol database at step N402. The operator then selects a desiredtreatment protocol from the displayed list of stored treatment protocolsat step N404. Once a treatment protocol has been selected, the operatorthen selects one of the treatment modules for execution at step N406. Atstep N406, the treatment modules available for execution are limited bythe stored treatment protocol module N208 to include only thosetreatment modules that are appropriate for the selected treatmentprotocol.

b. Tissue Assessment Module

Referring back to FIG. 34, the tissue treatment application N120 furtherincludes a tissue assessment module N212 configured to assess thecondition of the tissues of the patient and determine a recommendedtreatment protocol based on the assessed condition of the tissues. Thetissue assessment module N212 may analyze one or more types ofinformation regarding the tissue in order to assess the need fortreatment and determine the appropriate type of treatment.

FIG. 37 is a block diagram illustrating an embodiment of the tissueassessment module N212. In this embodiment, the tissue assessment moduleN212 may include a trigger point analysis module N506, which mayimplement assessment of selected tissues identified via visual ortactile inspection or via use of the impulse stimulator instrument 44with or without the use of electrical stimulation via the electrodes 14supported thereon. Once a recommended treatment protocol has beenidentified, the instrument control settings module N508 provides theappropriate instrument control settings and the treatment selectionmodule N510 directs the initiation of one or more treatment protocols.Any associated patient data and/or treatment protocol information may bestored in the database N122 (FIG. 34) by the trigger point analysismodule N506.

The trigger point analysis module N506 may assess the condition of thetissues of the patient by measuring tissue characteristics including,but not limited to, the response of the tissue to an applied forceimpulse, or any other aspect of the tissue related to, or correlatedwith, the health and condition of the tissue. The trigger point analysismodule N506 may use any known instrument to perform an additionalassessment of the condition of the tissues including, but not limitedto, an impulse stimulator instrument as described herein below, anelectromyographic electrode, or any other known measurement deviceappropriate for measurement of a tissue characteristic.

FIG. 38 is a block diagram illustrating an embodiment of a trigger pointanalysis module N506A. The trigger point analysis module N506A includesan instrument interface module N1102 to provide a GUI or other interfaceused by the operator to conduct measurements using one or more devices,a signal acquisition module N1104 to record a measurement signalobtained by the one or more devices, a signal analysis module N1106 toprocess the signal from the device to determine the condition of thetissue, and an instrument control settings module N1108 to provideinstrument control settings such as power settings, frequency ofpercussive impacts, frequency of applied acoustic pulses, and any otherparameter associated with a selected treatment protocol.

The trigger point analysis module N506A may be configured to guide theoperator through the steps of locating a landmark, initializing aninstrument for measuring a characteristic of a tissue in the vicinity ofthe landmark, and obtaining one or more measurements using theinstrument. The operator may be guided through measurements for one ormore landmarks using the trigger point analysis module N506A. Thetrigger point analysis module N506A may process the measurements of thecharacteristics of each landmark in combination with that landmark'sdegree of asymmetry to determine a recommended treatment protocol.

FIG. 39 is a flow chart illustrating an embodiment of a trigger pointanalysis module N506B. In this embodiment, an impulse stimulatorinstrument 44, referred to as an Impulse Wave subsystem in FIG. 39, isused to measure the reaction of a tissue to an applied force impulse.The impulse stimulator instrument 44 is situated at a specifiedanatomical landmark at step N1202. In an aspect, the specifiedanatomical landmark may be identified as a landmark associated with anervous, muscular, circulatory, bone, skin, connective tissue, and/orany other type of tissue structure that may be associated with asurgical site and is the target of the treatment preoperatively and/orpostoperatively. The anatomical landmark to be subjected to triggerpoint analysis may be displayed to the operator of the system 1111 viathe display 36. A force impulse is applied to the tissue at step N1204and a signal encoding the reaction of the tissue to the applied forceimpulse is acquired by the signal acquisition module N1104 at stepN1206. The signal analysis module N1106 analyzes the signal at stepN1208, and the instrument control settings are determined by theinstrument control settings module N1108 at step N1210. The instrumentcontrol settings are used by one or more treatment modules N218 toprovide a treatment to a tissue of the patient.

In an aspect, the signal analysis module N1106 may analyze any one ormore characteristics of the tissue in response to the force impulseapplied by the impulse treatment instrument 44 including, but notlimited to, the waveform of the tissue response. Non-limiting aspects ofthe waveform of the tissue response that may be analyzed by the signalanalysis module N1106 include the peak or maximum amplitude of thewaveform, the peak time, the rise time, the fall time, the frequency,and the area under the wave. Peak time, as defined herein, refers to thetime from the initiation of the waveform to the peak amplitude of thewaveform. Rise time, as defined herein, refers to the time elapsedbetween a waveform amplitude of 10% and 90% of the peak amplitude as theamplitude is rising to the peak amplitude. Fall time, as defined herein,refers to the time elapsed between a waveform amplitude of 90% and 10%of the peak amplitude as the amplitude is falling from the peakamplitude.

Without being limited to any particular theory, there is complexity inthe differing shapes of the waveforms associated with the response ofthe tissues to the force impulses. In an aspect, the signal analysismodule N1106 may generate a mathematical representation of the waveformof a tissue response and may further manipulate and interpret themathematical representation so as to define the amount of resistance,mobility, condition, and/or other characteristics of the tissue.

The signal analysis module N1106 is configured to analyze therelationship of all of the response factors associated with tissuetreatment and measurement, namely the analysis of the waveforms as theyrelate to tissues in general. The relation to the stiffnesscharacteristic (waveform peak), the hysteresis function (wave shape),and the frequency response provide valuable information regarding thestate of the measured tissue.

In an aspect, the measured waveform may be sinusoidal and may beinfluenced by tissue properties including, but not limited, to tissuemobility or resistance to mobility, fascia tension, muscle tonicity,connective tissue resiliency or inertia, local edema and any combinationthereof. Each such waveform may be characterized mathematically bydetermining the peak amplitude, peak time, rise time, fall time, andslew rate; these quantities may facilitate the calculation of frequencyresponse and certain ratios used to mathematically define the waveformcharacteristics. By analyzing the mathematics of the waveformcharacteristics, the condition of the tissues may be assessed usingpreviously determined relationships of waveform characteristics andtissue condition.

As the data are collected and logged and after all of the pertinentmathematic calculations are made, a summary display of the waveform andanalysis may be presented on the display 36 as illustrated in FIG. 7.The summary display may include a graphic display of the waveform, andthe pertinent data and derived ratios may be displayed for assessment bythe operator during a trigger point analysis. The data associated withthe summary display may be stored in the database N122 for use by thetissue treatment application N120A in determining the appropriatetreatment protocol and associated instrument control settings. Inaddition, the stored data associated with a trigger point analysis maybe incorporated into a more comprehensive database used to develop andrefine predictive diagnoses using methods of analysis including, but notlimited to, clinical assumptions and statistical models. Normal valuesassociated with the waveform analysis of healthy tissues may becompiled, stored, and used to compare normal versus aberrant tissues.Stored data may also be used to compare pre-treatment and post-treatmenttissues.

i. Instrument Control Settings Module

Referring to FIG. 37, the tissue assessment module N212 may furtherinclude an instrument control settings module N508 configured todetermine the control settings for the instruments to be used toadminister a treatment to the tissues of the patient. The controlsettings may be determined based on tissue readings taken via any of themeans of the system disclosed herein and via physical inspection guidedby veterinarian experience, as well as any additional characteristics ofthe tissues determined by the trigger point analysis module N506. In anembodiment, the instrument control settings module N508 may determineone or more control settings for the impulse stimulator instrument 44including, but not limited to preload tissue compression force,magnitude and frequency of a force impulse to be applied to the tissue.In another embodiment, the instrument control settings module N508 maydetermine one or control settings for the electrical stimulationafforded by the electrodes 14 including, but not limited to: magnitudeand frequency of an electrical pulse to be applied to the tissue.

ii. Treatment Selection Module

Referring to FIG. 37, the tissue assessment module N212 may furtherinclude a treatment selection module N510 configured to select one ormore treatment protocols based on the analysis of the tissues determinedby the 2D tissue assessment module N502, as well as other tissuecharacteristics determined by the trigger point analysis module N506.The recommended treatment protocols may be displayed to the operator asa list of treatment protocol options in an aspect. One or more treatmentprotocols may be selected from the displayed list by the operator inorder to initiate one or more treatments to the tissues of the patient.

c. Operator-Selected Treatment Module

Referring back to FIG. 34, the treatment protocol selection module N208includes an operator-selected treatment module N214 configured todevelop and implement a treatment protocol specified by an operator viathe input device 500 (shown in FIG. 2). In an aspect, theoperator-selected treatment module N214 may offer guidance to theoperator in the form of menus or suggested ranges for appliedstimulation frequencies, force impulse magnitudes, frequencies ofimpulse production, and any other parameter associated with thetreatment protocol selected by the operator.

In an aspect, the operator may specify a particular treatment mode andanatomical landmarks to be treated. An image may be displayed within aGUI display in this aspect to show the selected anatomical landmarks tobe treated. Upon selection of a particular anatomical landmark, the GUImay display the control settings of the instrument used to provide thetreatment to the tissues of the patient to the operator. The operatormay then specify the control settings of the instrument via the GUI.Alternatively, the GUI may guide the operator through a measurement ofanother characteristic of the tissue, and control settings of theinstrument may be recommended to the operator based on the measuredcondition of the tissue. The instrument control settings are used toconfigure the instrument used to administer the treatment to the tissuesof the patient.

III. Treatment Modules

Referring back to FIG. 34, the treatment protocol selection module N120Aselects a treatment protocol for a treatment of a tissue of a patient asdiscussed herein above. To implement the selected treatment protocol,the system 1111 may make use of one or more treatment modules such as,for example, a neural treatment module, a muscular treatment module, acirculatory treatment module, a bone or hard tissue treatment module, atendon/ligament or connective tissue module, a skin module, etc. In oneembodiment, the tissue treatment module N218 or any other treatmentmodule provides an interface with which the operator may configure theinstrument to be used to treat the tissue of the patient according tothe selected treatment protocol. In addition, each of the treatmentmodules may provide step-by-step guidance to the operator for placingthe instrument on one or more selected anatomical landmarks of thepatient and operating the instrument used to provide the treatmentspecified by the selected treatment protocol.

In an aspect, measurements of the condition of the tissues including,but not limited to, the response of the tissue in reaction to appliedforce impulses may be obtained. The post-treatment measurements may bestored in the database N122 in an embodiment.

Detailed description of a general tissue treatment module N218 isprovided herein below.

a. Tissue Treatment Module

Referring back to FIG. 2, in one embodiment, the data acquisitioncircuitry 45 and the software code 38 thereof includes a preoperativeand postoperative treatment (“PAPT”) module N218 configured to guide theoperator through pre-operative and post-operative treatments associatedwith one or more surgeries associated with one or more anatomicallandmarks in accordance with a selected treatment protocol. In thisaspect, the PAPT module N218 may apply percussive impacts to tissuesusing the impulse stimulator instrument 44. Other treatment protocolsincluding, but not limited to, electrical stimulation applied to tissuesin vicinity of the surgical site may be implemented in otherembodiments. The electrical stimulation may be in the form of electricalstimulation protocols described above.

FIG. 40 is a block diagram illustrating an embodiment of a PAPT moduleN218A. The PAPT module N218A may include a tissue image display moduleN1602 to produce a GUI used to guide the operator through a treatment oftissue associated with a surgical site. Examples of tissues adjacent asurgical site that may be treated with the system include, withoutlimitation, nerves, vasculature, muscle, connective tissue such asligaments and tendons, Golgi tendon organs, fascia, cartilage,tendon/muscle junctions, tendon/bone junctions, skin layers, etc.

An instrument configuration module N1604 may be used to specify thecontrol settings of the impulse stimulator instrument 44 used toimplement a treatment of the tissue including, but not limited to themagnitude and frequency of the applied force impulse, and the durationof the treatment. A trigger point frequency analysis module N1606 mayguide the operator through an analysis in which the stimulatorinstrument is used to measure the response of the tissue through a rangeof frequencies of the applied force impulse and to determine one or moreinstrument control settings based on an analysis of the measured tissueresponse. The instrument interface module N1608 provides a GUI or otherinterface used by the operator to operate the impulse stimulatorinstrument while implementing a selected treatment protocol.

Examples of tissue image displays 1700 are illustrated in FIG. 41-43A. Atissue image display 1700 may include a surgical site tissue image 1702illustrating the location of tissue adjacent a surgical site to aid theoperator in locating the appropriate region for treatment. For example,as illustrated in FIG. 41, the surgical site tissue image 1702 depictsthe tissue adjacent a hip surgical site such as in the case of a hiparthroplasty. FIG. 42 illustrates a surgical site tissue image 1702depicting the tissue adjacent a knee surgical site such as in the caseof a knee arthroplasty. FIG. 43 illustrates a surgical site tissue image1702 depicting the tissue adjacent a foot surgical site such as in thecase of a plantar fasciitis or pes equines. FIG. 43A illustrates asurgical site tissue image 1702 depicting the tissue adjacent a shouldersurgical site such as in the case of a shoulder arthroplasty.

As can be understood from FIG. 41 (and in a similar fashion with respectto FIGS. 42-43A), in an aspect, the location of anatomical landmarks1704A-1704D identified by a treatment protocol selection module of thedata acquisition circuitry 45 and the software code 38 may besuperimposed on the tissue image 1702. The frequency at which the forceimpulses are applied to the tissues may be displayed and/or specifiedusing a GUI control element such as the slider control 8910 illustratedin FIG. 41. In this example, a hip region is illustrated in the tissueimage 1702, and the tissues and anatomical landmarks 1704A-1704E pertainto a human hip region. Of course, depending on what surgical site isbeing treated and how the treatment system 1111 is configured, thetissue image 1702, tissues and anatomical landmarks can pertain to anypotential surgical site including without limitation hips, knees, orfeet, as indicated by FIGS. 41-43A.

The tissue display 1700 may further include controls (e.g., buttons,sliders, etc.) and readouts (e.g., gages, graphs, etc.) 8901-8921 usedto control and understand various aspects of the treatment of thetissue. In one embodiment, the GUI 1700 depicted in FIG. 41 is displayedon the display 36 of FIG. 2 once the setup of the system 1111 has beenachieved as described below with respect to the GUI 8860 of FIG. 44. Asindicated in FIG. 41, the GUI 1700 includes the anterior hip regionimage 1702 with its trigger points 1704A-1704D. The GUI 1700 alsoincludes an input device 114 with touch sensitive screen buttons“Reference”, “Select Map”, “Map”, “Trigger Point”, “Notes”, “Print”, and“Exit” 8902-8904 and 8906-8909. The input device 114 of the GUI 1700also includes touch sensitive screen sliders “Frequency”, “Force”,“Pulses”, “Mode”, and “Preload” 8910-8914. Finally, the GUI 1700 alsoincludes “Auto Stop” and “Thresholds” indicates 8915 and 8916 and agraphical display 8917 to illustrate the treatment and “In Tolerance”,“Current”, “Previous” and “Total” indicators 8918-8921.

In one embodiment, the user interface contains various controls that aidthe user by providing control and treatment feedback information. Theuser can select the treatment node map by selecting “Select Map” 8903,and the treatment nodes 1704A-1704D can be caused to display on thetissue image 1702 by selecting “Map” 58904. The “Reference Button” 8902is used to store information regarding the anatomical area of treatment,treatment overview and rationale, treatment goals and or expectedresponses.

Functionality can be quickly switched from a protocol to a trigger pointby toggling between protocols and trigger points via “Select Map” 8903to select the type of therapy desired. The notes button 8907 brings up awindow to allow the user to enter information in a text format via thekeyboard. General treatment controls include frequency, force and limits8910-8912. While the computer calculates the frequency, the user canoverride it by touching the screen and moving the digital slider.However, the force and limit have defaults that are parameters selectedby the user to determine how much power will be used and the maximumnumber of impulses that can be delivered. The selection mode 8913 isused to choose what harmonic frequency is chosen within the range offrequencies of 0.1 to 12 Hz.

There are different input frequencies depending on whether one isattempting to stimulate a nerve, voluntary muscle fiber or involuntarymuscle fiber. The ranges are Alpha 7-12, Theta 4-7, and Delta 0.1 to 4Hz. The selection mode slider 8913 allows the user to dynamically choosethe proper harmonic dynamically.

The preload function 8914 changes the amount of pressure that is used tocompress the tissue before the treatment applicator begins to produceimpulse. Because surgical target site and different types of treatmenttarget tissue may vary widely in its physiological characteristics andtolerances, varying amounts of pressure can be used. Preload 8914provides a way to control this pressure without having to changetreatment heads.

As treatment is progressing, information about the tissue response isshown on a strip chart 8917. Information includes real time output fromthe sensor showing changes in tissue tone, changes in tissue frequencyresponse and changes in wave shape characteristics. If auto-stop ischosen 8915, these signals will be interpreted and the device willautomatically stop treatment based upon a definable tolerance. Forinstance, if a tolerance of 3% is used for tissue stiffness, the devicewill stop treatment based upon receiving a predefined number of impulsesthat are all within 3% of each other.

Thresholds 8916 may be turned on or off to give the user a visual scaleof how the treatment parameters are progressing in real time with regardto the auto-stop parameters. As the treatment progresses the real timemeasurements are tabulated in 8918 through 8921. “In tolerance” 8918displays the impulses that fall within the pre-defined toleranceindications. “Current” 8919 displays the number of impulses that havebeen delivered during the activation of the treatment head during theactive treatment while “previous” 8920 shows the previous number ofimpulses during the last treatment application and “Total” 8921 displaysthe total number of impacts delivered during the entire treatment. Afterthe treatment is concluded the users may print the screen by selectingthe “print” button 8908 or the user may simply exit the protocol screenby touching the “exit” button 8909.

FIG. 44 is a flow chart illustrating an embodiment of the tissuetreatment module N218A. The tissue image 1702 and controls for theimpulse stimulator instrument 44 may be displayed in the tissue display1700 at steps 1802 and 1804. The tissue treatment module 218A determineswhether instrument control settings have been specified using the storedtreatment protocol module N210 or tissue assessment module N212 at step1806. If no instrument control setting has been specified, theinstrument control settings are populated with default values at step1808. Once the default values have been loaded, the tissue treatmentmodule N218A determines if a trigger point analysis is desired to refinethe default settings at step 1810. If desired, a trigger point analysisis performed at the anatomical landmark at step 1812.

If instrument control settings were identified at step 1806, thesettings are loaded into the tissue display 1700 at step 1814. Ananatomical landmark to be treated is displayed on the tissue display1700 at step 1816. If a trigger point analysis was conducted, therecommended instrument control settings are loaded into the tissuedisplay 1700 at step 1818, and the treatment is implemented at step1820.

As illustrated in FIG. 45, which is an isometric view of an embodimentof the physical therapy treatment system or preoperative andpostoperative tissue treatment system 1111 for treating the tissue of apatient, the system 1111 may include a case or housing 8800 thatencloses and protects the system. The case 8800 may be secured in aclosed state via latches 8802 as illustrated in FIG. 45. The case 8800may also include a handle 8804 that extends from the sidewalls or shell8806 of the case.

As shown in FIG. 46, which is an isometric view of the treatment system1111 of FIG. 45 with the case 8800 opened up to reveal the display 36and input device 114, the case 8800 has a clamshell arrangement with atop sidewall 8806A and a bottom sidewall 8806B pivotally secured to eachother via a hinge 8810. The computing device 45 of the system 1111,along with the display 36 and input device 114 are contained in thebottom sidewall 8806B. The computing device 45 may be as described abovewith respect to configuration, components and operation.

The system 1111 may include the impulse stimulator instrument 44 withelectrodes 14 supported on the tip of the instrument 44 as can beunderstood from FIG. 2, as discussed above. The impulse stimulatorinstrument 44 may be as described above with respect to configuration,components and operation. The impulse stimulator instrument 44 iscapable of being electrically coupled to the computing device 45 via anelectrical cable 8812. Multiple types of probes 2204 similar to thosedescribed above are provided for coupling to the impulse stimulatorinstrument 44.

FIG. 47 depicts a GUI 8840 for display on the display 36 depicted inFIG. 46, wherein the GUI 8840 is associated with the setup of the system1111 for the treatment of a patient hip region, the hip being the targetof an arthroplasty or other surgical procedure. While this discussion isgiven in the context of the hip being the surgical target, thisdiscussion is given merely as one example, and the system 1111 and itstreatment methods may by applied to any other location on the patient'sbody and in the context of preoperative and/or postoperative treatmentassociated with any other type of surgical procedure.

As shown in FIG. 47, the GUI 8840 includes surgical site selectionwindow 8822, wherein, as indicated by Arrow A, “right hip” has alreadybeen selected from other listed sites including, for example, rightknee, right shoulder, right ankle, right wrist, right foot, cervicalvertebrae, lumbar vertebrae, radius, tibia, femur, heart, liver, lungs,etc. The surgical site can include any location on or system of thepatient including, for example and without limitation, any skeletal boneor joint, any connective tissue, any body organ or system, any locationor side associate with these body elements, etc. The GUI 8840 alsoincludes a treatment region selection window 8824, wherein, as indicatedby Arrow B, “femoral head replacement” has already been selected fromother listed hip treatments applicable to the hip, such as, for example,femoral head resurfacing, cartilage repair, tendon repair, etc. As aresult of the selection of the “femoral head replacement” at Arrow B inwindow 8824, an image 8846 of a right anterior region of a patient hipis depicted in an image window 8828. Where the associated treatment mayrequire other views of the hip, such as, for example, a lateral viewand/or a posterior view, such views will be provided on the display andmay be toggled between during the course of the treatment.

As indicated in FIG. 47, a trigger point 8850 for an associatedtreatment is shown in the image 8846. Touch sensitive screen buttons“Reference”, “OK” and “Cancel” 8831-8833 are also included in the GUI8840. In one embodiment, useful reference information may be accessed bythe operator by selecting button 8831. Pressing button 8832 will returnto the treatment screen and setup the system using the settings found inthe selected treatment protocol. Pressing button 8833 will cause theselection screen to return to the treatment screen in its' last mode.

In one embodiment, the system 1111 disclosed herein can be used toimprove the surgical outcome following a surgical procedure such as, forexample, a hip, knee or shoulder arthroplasty. For example, in oneembodiment, the system can be used to provide three treatments with thesystem 1111 one to two weeks before surgery and a series of ten totwelve treatments following surgery. There would be a two to four dayrest between treatment cycles for the preoperative and postoperativetreatments. The postoperative treatment would begin within two to tendays after the surgery, based on patient tolerance.

As can be understood from FIG. 41, in one example of a hip arthroplastytreatment deliverable via the system 1111, treatment via the instrument44 of the system is applied to the anterior, posterior, and lateralaspects of the hip. As can be understood from FIG. 42, in one example ofa knee arthroplasty treatment deliverable via the system 1111, treatmentvia the instrument 44 of the system is applied to the anterior, lateraland dorsal aspects of the knee. In one example of a shoulderarthroplasty treatment deliverable via the system 1111, treatment viathe instrument 44 of the system is applied to the anterior, posteriorand lateral aspects of the shoulder. In one embodiment of theaforementioned hip, knee and shoulder treatments, placement of thetreatment head 13 (shown in FIG. 1) should be placed approximately twoto three centimeters from the surgical incision or puncture wound. Ascan be understood from the discussion of the system 1111 provided above,the treatment settings can be individually set or automatically byselecting the hip, knee, or shoulder treatment algorithm forarthroplasty. In one embodiment, the default treatment settings are asfollows: pulse limit 100; Force 20 lbs.; Frequency 8.6 Hz and Preload 1.

As can be understood from the preceding discussion, in a firstembodiment of the system, the system 1111 is a system for treatingtissue associated with a desired outcome of a surgical procedure on apatient. The system 1111 includes a display screen 36, a computerprocessor 34, an input device 500, a memory 37, and a treatment head 44.The display screen is configured to display information associated withthe treatment of the tissue. The computer processor is configured toprovide for the selection of a type of surgery and a surgical locationon the patient. The surgical location is shown on the display screen asa part of an image 1702 of a patient region associated with the surgicallocation. A treatment point 1704A-D, which is associated with thetreatment of the tissue, is identified on the image. The input device isin electrical communication with the display screen and configured toreceive information associated with the treatment of the tissue to bedelivered at the treatment point. The memory is in electricalcommunication with the CPU and includes treatment parameters associatedwith the treatment of the tissue to be delivered at the treatment point.The treatment head is in electrical communication with the computerprocessor and configured to deliver at least one of impulse and/orelectrical therapy energy to the treatment point in accordance with thetreatment parameters.

Also, as can be understood from the preceding discussion, in a secondembodiment of the system, the system 1111 is a system for treatingtissue associated with a desired outcome of a surgical procedure on apatient. The system includes a database N122 contained in a memory 37.The database contains data categorized by surgical locations. The dataincludes a plurality of anatomical images 1702, a plurality of treatmentpoints 1704A-D identified on the plurality of anatomical images, and aplurality of treatment protocols N210 associated with plurality oftreatment points. The system is configured such that a selection of aspecific surgical location and a specific surgical procedure to occur atthe specific surgical location causes an image 1702 of a specific regionof the patient to be displayed on a display of the system, the image ofthe specific region including the specific surgical location. At leastone treatment point 1704A-D is caused to be displayed on the image ofthe specific region. The treatment point is stored in the database aspart of the plurality of treatment points and associated with at leastone treatment protocol of the plurality of treatment protocols.

In a version of the second embodiment of the system 1111, the system isalso configured such that a selection of the specific surgical locationfrom the database provides the ability to input information into thesystem regarding the specific surgical procedure to occur at thespecific surgical location.

In a version of the second embodiment of the system 1111, when thespecific surgical location is a knee, the surgical procedure comprisesat least one of the following: total arthroplasty; uni-compartmentalarthroplasty; ligament repair; meniscus repair, torn or ruptured tendonrepair, or torn or ruptured muscle repair. Also, the specific regioncomprises a knee region comprising a distal region of a femur and aproximal region of a tibia. Finally, when the at least one treatmentpoint is caused to be displayed on the image of the specific region, theat least one treatment point is displayed on at least one of thefollowing locations: a distal femur proximal to the patella; a medial orlateral epicondyle; a medial or lateral meniscus; a medial or lateralcollateral ligament; a patella tendon; a lateral head of a fibula; atibial tuberosity; a proximal tibia; or an adductor tubercle.

In a version of the second embodiment of the system 1111, when thespecific surgical location is a hip, the surgical procedure comprises atleast one of the following: femoral head total arthroplasty; femoralhead resurfacing; ligament repair; torn or ruptured tendon repair; tornor ruptured muscle repair; or femur fracture repair. Also, the specificregion comprises a hip region comprising a proximal region of a femurand region of an iliac surrounding a hip joint. Finally, when the atleast one treatment point is caused to be displayed on the image of thespecific region, the at least one treatment point is displayed on atleast one of the following locations: an anterior superior iliac crest;an inguinal ligament; a greater or lesser trochanter; a trochantericbursa; an anterior or lateral proximal femur; a proximal hamstringtendon; or a proximal hamstring muscle.

In a version of the second embodiment of the system 1111, when thespecific surgical location is a shoulder, the surgical procedurecomprises at least one of the following: rotator cuff repair; totalshoulder arthroplasty; shoulder joint resurfacing; arthroscopicacrominosplasty; ligament repair; humerus fracture repair; claviclefracture repair; torn or ruptured tendon repair; torn or ruptured musclerepair; impingement of scapula; removal of calcified deposits in thesupraspinatus or related tendons; or Mumford procedure. Also, thespecific region comprises a shoulder region comprising a proximal regionof a humerus and a lateral region of at least one of a clavicle or ascapula. Finally, when the at least one treatment point is caused to bedisplayed on the image of the specific region, the at least onetreatment point is displayed on at least one of the following locations:an anterior acromioclavicular joint; an anterior acromion; an anteriorcorticoid process; an anterior glenohumeral joint; an anterior greateror lessor tubercle; a spine of a scapula; a supraspinatus muscle; asubacromaial bursa; a grove for a bicep tendon; or a deltoid muscle.

In a version of the second embodiment of the system 1111, the systemalso includes a treatment head 44 electrically coupled to the databaseand configured to deliver at least one of impulse and/or electricaltherapy energy to the treatment point in accordance with the at leastone treatment protocol of the plurality of treatment protocols.

As can be understood from the preceding discussion, in a thirdembodiment of the system 1111, the system is for delivering at least oneof preoperative or postoperative therapy to tissue associated with asurgical outcome. The system 1111 includes a database N122, an inputdevice 500, a display device 36, a treatment head 44, and a CPU 34. Thedatabase includes a plurality of anatomical images 1702 respectivelycorrelated to a plurality of surgical target sites. The input device isconfigured to allow a selection of a specific surgical target site fromthe plurality of surgical target sites. The CPU is in communication withthe database, input device, display device and treatment head. When thespecific surgical target site is selected from the plurality of surgicaltarget sites, the CPU causes a respective specific anatomical image tobe displayed on the display and treatment points 1704A-D to be indicatedon the displayed specific anatomical image. The CPU causes the treatmenthead 44 to function in accordance with a treatment protocolcorresponding to the treatment points.

In a version of the third embodiment of the system 1111, the inputdevice 500 includes a touch screen or a keyboard. In a version of thethird embodiment of the system 1111, the plurality of surgical targetsites includes surgical procedures. In a version of the third embodimentof the system 1111, the treatment head 44 is configured to deliver atleast one of impulse and/or electrical therapy energy in accordance withthe treatment protocol. In a version of the third embodiment of thesystem 1111, the database further includes a plurality of treatmentprotocols correlated to a plurality of treatment points correlated withthe plurality of surgical sites.

As can be understood from the preceding discussion, in an embodiment ofthe treatment method, the method is for delivering at least one ofpreoperative or postoperative therapy to tissue associated with asurgical outcome. The method includes: 1) imputing at least one of asurgical procedure or surgical target site into an apparatus, theapparatus displaying on a display an anatomical image comprising thesurgical target site, the apparatus also displaying treatment points onanatomical landmarks shown in the anatomical image, the apparatuscorrelating the treatment points with the at least one of the surgicalprocedure or surgical target site, the apparatus correlating a treatmentprotocol with the treatment points; and 2) using a treatment head of theapparatus to apply therapy to locations on a patient that correspond tothe treatment points, the therapy being configured according to thetherapy protocol controlling the treatment head.

In one version of the method, when the surgical procedure concerns aknee or the surgical target site comprises a knee, the surgicalprocedure comprises at least one of the following: total arthroplasty;uni-compartmental arthroplasty; ligament repair; meniscus repair, tornor ruptured tendon repair, or torn or ruptured muscle repair. Also, theanatomical image comprises a knee region comprising a distal region of afemur and a proximal region of a tibia. Finally, when the treatmentpoints are displayed on the anatomical landmarks shown in the anatomicalimage, the treatment points are displayed at least some of the followinglocations: a distal femur proximal to the patella; a medial or lateralepicondyle; a medial or lateral meniscus; a medial or lateral collateralligament; a patella tendon; a lateral head of a fibula; a tibialtuberosity; a proximal tibia; or an adductor tubercle.

In one version of the method, when the surgical procedure concerns a hipor the surgical target site comprises a hip, the surgical procedurecomprises at least one of the following: femoral head totalarthroplasty; femoral head resurfacing; ligament repair; torn orruptured tendon repair; torn or ruptured muscle repair; or femurfracture repair. Also, the anatomical image comprises a hip regioncomprising a proximal region of a femur and region of an iliacsurrounding a hip joint. Finally, when the treatment points aredisplayed on the anatomical landmarks shown in the anatomical image, thetreatment points are displayed at least some of the following locations:an anterior superior iliac crest; an inguinal ligament; a greater orlesser trochanter; a trochanteric bursa; an anterior or lateral proximalfemur; a proximal hamstring tendon; or a proximal hamstring muscle.

In one version of the method, when the surgical procedure concerns ashoulder or the surgical target site comprises a shoulder, the surgicalprocedure comprises at least one of the following: rotator cuff repair;total shoulder arthroplasty; shoulder joint resurfacing; arthroscopicacrominosplasty; ligament repair; humerus fracture repair; claviclefracture repair; torn or ruptured tendon repair; torn or ruptured musclerepair; impingement of scapula; removal of calcified deposits in thesupraspinatus or related tendons; or Mumford procedure. Also, theanatomical image comprises a shoulder region comprising a proximalregion of a humerus and a lateral region of at least one of a clavicleor a scapula. Finally, when the treatment points are displayed on theanatomical landmarks shown in the anatomical image, the treatment pointsare displayed at least some of the following locations: an anterioracromioclavicular joint; an anterior acromion; an anterior corticoidprocess; an anterior glenohumeral joint; an anterior greater or lessortubercle; a spine of a scapula; a supraspinatus muscle; a subacromaialbursa; a grove for a bicep tendon; or a deltoid muscle.

In one version of the method, the treatment head is configured todeliver at least one of impulse and/or electrical therapy energy to thetreatment points in accordance with the therapy protocol.

The foregoing merely illustrates the principles of the invention.Various modifications and alterations to the described embodiments willbe apparent to those skilled in the art in view of the teachings herein.It will thus be appreciated that those skilled in the art will be ableto devise numerous systems, arrangements and methods which, although notexplicitly shown or described herein, embody the principles of theinvention and are thus within the spirit and scope of the presentinvention. From the above description and drawings, it will beunderstood by those of ordinary skill in the art that the particularembodiments shown and described are for purposes of illustrations onlyand are not intended to limit the scope of the present invention.References to details of particular embodiments are not intended tolimit the scope of the invention.

What is claimed is:
 1. A system for treating soft tissue of a patient,the system comprising: a treatment head including a probe and anelectrode operably coupled to the probe, the probe and electrodeconfigured to respectively deliver a mechanical force impulse and anelectrical stimulation to the soft tissue when placed in operablecontact with the soft tissue; and a computer portion including a CPU andconfigured to coordinate the delivery of the mechanical force impulseand electrical stimulation relative to each other.